I would like to be an abolitionist also, and I think I have some pretty good reasons for wanting to do so, to think that way, to consider myself an abolitionist.

Moral status is for many ethicists independent of the claimant’s social position in the ‘hierarchy’ (phylogenic scale, in this case) or their role in socially constructing ethical theory.  In other words, moral status is not a private social product; it’s public to the extent that it is widely accorded the belief that it’s morally true (in some meaningful sense).

In other words, to claim that nonhumans ought not to be brutalized is somehow believed to be a morally true statement, and the place and status of the ‘ought’ will be thought to be correct.  Is ‘ought’ indicative of a duty that is ‘owed’ to the claimants (in this case, those for whom the claim is made)?  Yes.

To claims that animals ought NOT to be brutalized is further qualified by ‘in science’ or ‘in the name of science’.

There are at times qualifiers which modify the ‘ought’ (as in ‘just war’ theories), and I do NOT believe that science qualifies as a ‘just war’ modification of our obligation to not harm vulnerable sentient beings.  Lab animals are not individually out to harm us deliberately; if rodents were to consume our grain or other crops, we with capacity to construct our social relations with the ecological ‘others’ could be expected to do so in order to protect OUR interests without negating ours.

We have many moral illustrations of the long history of attempting to benignly address the needs of others without harming ourselves – some more gracious, some more loving, some more brilliant than others.  Consider one which many of us know: the Hebrew proscription (as in the narrative about Ruth, Naomi, and Boaz) to leave the corners of the field ungleaned so that the poor scavengers could find enough to get by with some reasonable effort.  They didn’t have a free food pantry as such, but they were given (by conscious forethought) enough to take by a modest amount of effort on their parts – and it was 100% plant-based food, too, unlike many of the free food pantries you and are asked to support, which conflicts with many of OUR deeply-held moral values about not trading off the interests of some – the animals – in order to address the interests of others – the class of persons benefitting from our exploitation and abuse and murder).


But this illustration shows how those without ready access to meeting their needs are seen as morally significant persons with interests that we ought to consider.  Short of socializing all effort and recruiting these persons (perhaps they were antisocial or uncooperative, but the narrative doesn’t paint them that way, nor even suggest as much), the social ‘solution’ seems to have been widely affirmed – at least b y those who subscribed to the moral teachings of ‘leaving the corners of the fields’ (of grain) for the outsiders to glean after the ‘main’ gleaning had been finished.

Was this a potential ‘waste’ of edible grain?  Perhaps.  Is there a risk of inefficiency?  Perhaps.  But the system was widely known.

In thinking about nonhumans in the context of our (socially constructed) ‘duties’ to care for our fellow human beings AND to provide extra for them (as a safety net when they are injured or get ill, whether because they have been personally careless or inept, or because they were vulnerable to the malice of others), one claim (the appeal to do science on behalf of future victims and potential victims) runs afoul of the prior moral claims of nonhumans to not be harmed by direct intentions, by direct interventions.

Given that there are these claims to provide a medical safety net, even those who favor those socially-constructed claims can understand that killing or harming unwilling animals because of their vulnerability is morally objectionable.  In other words, it can REASONABLY be considered objectionable based on the physical characteristics of these sentient nonhumans.

Given the ‘moral difficulty’ of solving these problem, compromise solutions are often presented, as the ‘public option’ is offered in the USA as a compromise between single-payer and what single-payer’s opponents call ‘market-driven’ solutions.  SP friends are unhappy with the compromise; free-market advocates are unhappy; whether the compromise works for the greater benefit and satisfaction of the vast majority is not yet known (and can only be reasonably predicted).

In the vegetarian (and vegan) world, we have the 10% solution, which is offered to meateaters to consider life with meatless meals.  One meatless day per week would be about 1/7 (or 14.2857%), which they TERM ‘the 10% solution) in that (THEORETICALLY) it could free about 10% of agricultural land (and presumably return it to a ‘wild’ state (though it’s likely to be exploited by real estate developers).  The term 10% is widely-known in monotheistic religious contexts when talking about ‘tithing’ (giving 10% ‘off the top’).

But I’ve long suggested the 30% solution as follows:

The overwhelming proportion of researchers in the life sciences (whether they use animals or not) are researchers only, not fund raisers.  They depend upon funding (for laboratories, salaries, supplies, and animals).  They seek funding from corporations, government grants, private foundations, individual benefactors, and some other sources.  Grant money typically has an overhead percentage that goes to the hosting institution(s).

I propose that a ‘first 30%’ be given to fund aggressive research INTO nonanimal research methods – methodological research into developing and validating nonanimal research methods.

This suggestion itself is likely to make me (in the aggregate) far MORE enemies in the vegan world than I’ve already made in my 30-35 years of veganism, but let it be discussed.

It’s not abolitionism; it’s likely to be termed ‘welfarism!

However, short of addressing the CLAIM that is widely-accepted that some things NEED to be researched and understood and that, to date, nonanimal research methods (for doing WHAT WE THINK WE NEED TO DO/RESEARCH) are not yet available with a confidence level sufficient to warrant their use instead of animal methods (not in conjunction with animal research methods), we have no quick response EXCEPT the moral argument that animals are not ours to eat, wear OR EXPERIMENT UPON.

(I accept fully that NO person is ours to eat, wear, or experiment upon, and I wish folks like Bill Maher and the ‘social deconstructionists’ we accept into our camp would understand that some interpersonal social behaviors that are widely accepted by the morally casual’ either are or lend themselves more to experimenting upon sentient beings (and as such, should be frowned upon and denounced.  But I digress.)


But let’s do a little analysis here of my suggested “30% solution” that would fund the development and validation of nonanimal research methods in the same way that tobacco taxes and penalties on tobacco companies fund aggressive health education about the risks and harmful effects of tobacco use.  In a libertarian political context (and more and more dietary vegans are TERMING themselves libertarians; I’ll see HUNDREDS of such ‘libertarian vegans’ at the upcoming Boston Vegetarian Food Festival), what else can we do?  Yes, it’s a political and moral compromise, and we’re not coming back to the animals OR ‘the district’ with the solutions we had wanted.  But in the same spirit that we send elected representatives to our democratic legislative bodies and expect them to bring SOMETHING back that is better than no representation at all, is the 30% solution a totally contemptible half-way ‘solution ‘ in light of the historical hope that we WILL – with the intelligence, ingenuity, collaboration, funding, and moral will to do so – be able to develop somehow the social consensus that replacing animal models in ALL basic science (as in toxicology and other research, including military wound research) is both desirable AND feasible, and we offer a provisional means to help our societies get to that point of total abolition of animal research?

Here’s the current downside of NOT replacing animal models:

Not only are animals sacrificed in research facilities, but the credibility of the moral claim that NO animals are ours to eat, wear OR EXPERIMENT UPON is diminished BECAUSE we’ve already consented to let them be experimented upon BECAUSE of the moral gravity of the moral claim that our fellow humans need a medical ‘safety net’ that is perpetually improved.

Yes, we are being asked to trade off our abolitionism for two things: (a) funding (finite) and (b) widespread public support for the belief – consensus – that research on animals is something that is morally objectionable, needs to be replaced, and MUST be replaced within the foreseeable future.  The ‘win’ here is that we work for the public agreement on the 3 Rs agenda, which they don’t FORMALLY approve or support AT THIS TIME.

This suggestion MAY be all wrong, but I’d like to see us incubate a discussion.

I further suggest that CLAIMS by researchers to love their animals because we can see that they love their dog(s) and/or cat(s) cannot be trusted BECAUSE they are not signing on to the replacement agenda in the 3Rs: reduce, refine, and replace.

For nearly 3 decades of street outreach, particularly at Harvard, when I see that I can make NO headway with researchers (some really DO want to see some possible consensus, perhaps because they tend to like me – as a bright person, accepted collegially), I suggest that the ACID TEST of whether or not they ARE talking in good faith is their public and wholehearted acceptance of the 3 Rs standard and THEIR willingness to fund and support replacement research.  Short of that WHOLEHEARTED acceptance of the 3 Rs to the point of sharing funding, I call their ‘moral pleas’ (of innocence and good will in a morally difficult context) ‘mere huff’ (and something to be publicly protested).

Of course, if NO experiments on nonhumans have ANY applicability to human beings [http://www.safermedicines.org/faqs/faq16.shtml], then the 3Rs is moot and we should reject all medical experiments on animals (for human interventions) as unscientific .  However, the 3 Rs seems to suggest that (a) some experiments on nonhumans are less than optimal and should be replaced; (b) some experiments on nonhumans are less than optimal and should be refined, and (c) some experiments on animals are morally objectionable but AT THIS TIME are scientifically necessary to get WHAT WE THINK  we need to know (and we may find that there are other ways to reach the goal of health populations without pharmaceutical or surgical interventions.

That’s not how the 3 RS is always read, but closer study of the 3 Rs does seem to suggest that as a valid reading.

At the Longwood Medical Area’s annual lab equipment 2-day exhibition, a number of research facilities DO offer nonanimal research methods, but in that context there’s a certain anxiety about billing themselves as nonanimal research method developers.  But here are some of the non-ethical ‘drivers’ or forces moving less-than-concerned animal researchers towards replacement of animal models wherever possible:

(a)    Cost – experimental animals are VERY expensive to (i) purchase, (ii) house, and (iii) maintain, and (iv) hygienically and safely dispose of

(b)   Contagion – working with experimental animals poses some health risk to human researchers AND to those (i) associated with those human researchers [cleaning cages, cleaning labs, in the department, traveling with them on public transportation, family members and friends, other colleagues] AND (b) those who deal in animals [hopefully HIPAA-compliance in the USA reduces some of this concern, but it’s still there].

(c)    Ethical discord among researchers and their communities

(d)   Risk of violence developing among researchers who work with animals (a recent study, I believe at Cornell, showed that interpersonal violence among researchers who deal with animals is potentially volatile).

(e)   Potentially better results from nonanimal research methods

(f)     Repeatability of experiments is easier and cheaper, and science is nothing if not repeatable.

(g)    Training (surgical training specifically) needs to be done FAR more times than is affordable using animal-based models for surgical training; healthcare is plagued with medical errors, and systems- research, including work offered by Dr. Donald Berwick of Cambridge-based IHI – the Institute for Healthcare Improvement, suggests that we need to require much higher levels of surgical practice and that is not affordable without shifting to simulation modules, as offered by SimuLab and a few other providers (in the USA).

So let’s think NOW about the 30% solution and, as we near the tipping point for shifts in research paradigms, perhaps th entire house of cards (or most of it) will fall IN OUR LIFETIMES.

Vigorous debate is encouraged!

Labels: abolition, abolitionism, abolitionist, animal rights, animal-rights, medical, medicine, research, science, welfarism

30 Scientists Accuse Tufts Researchers of Ethical Violations-- Nuremberg Code



ALLIANCE FOR HUMAN RESEARCH PROTECTION
A Catalyst for Public Debate: Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org



FYI
A report in the business forum, Zikkir, "Out of Sight" was prompted by the publicity surrounding the $79 million settlement of Pfizer's unethical Trovan experiment conducted on Nigerian infants.
http://www.ahrp.org/cms/content/view/571/72/.



The Zikkir article touches on the problems related to the US pharmaceutical industry's increased outsourcing of clinical trials to off-shore locations, mostly in underdeveloped countries including Eastern Europe and Russia which do not conform to ethical restraints mandated by the Nuremberg Code or the Declaration of Helsinki. http://zikkir.com/business/6259?wscr=1024x768.



An in-depth report by the Institute of Science in Society, "The Golden Rice
Scandal Unfolds," demonstrates that academics who are shielded by the US
government seal of approval, have been conducting medical experiments that
are clearly prohibited by the Nuremberg Code. The article focuses on a
series of recent unethical Phase II trials conducted by Tufts University
researchers, who tested genetically modified "Golden Rice' (GR2) on children
in the U.S. exposing them to "an unapproved experimental genetically
modified rice enhanced in pro-Vitamin A that has the potential to cause
birth defects and developmental abnormalities."

The questionable experiments-which ISIS described as "an exercise in how not to do science"--are:

1. Project NCT 00680355.(10) Bioavailability of Golden Rice Carotenoids in Humans.
http://clinicaltrials.gov/ct2/show/record/NCT00680355?term=golden



2. Project NCT 00082420. Retinol Equivalence of Plant Carotenoids in Children.
http://clinicaltrials.gov/archive/NCT00082420

The experiment compared the vitamin A value of b-carotene in oil capsule, spinach and Golden Rice - recruited 72 children 7 to 9 years of age. The starting date of the experiment was September 2004, it ended November 2005.

3. Project NCT 00680212. Vitamin A Equivalence of Plant Carotenoids in Children.
http://clinicaltrials.gov/ct2/show/record/NCT00680212?term=golden


In this experiment, researchers recruited 72 children 6 to 8 years of age and registered start and finish dates July 2008 and January 2009.

The ISIS report (submitted to the FDA in March, 2009) states:
"The Golden Rice Project website [6] (accessed 17 March 2009), stated that "Golden Rice has gone through many tests since it was first obtained" Nine items are listed; but no feeding trial on animals among them." See: http://www.i-sis.org.uk/goldenRiceScandal.php



"Golden Rice" has been touted as a humanitarian effort to resolve vitamin A deficiency. However, it has met with significant opposition from environmental and anti-globalization activists who view it as a commercial threat.

For example, Dr. Vandana Shiva called it "a hoax:"

"Unfortunately, Vitamin A rice is a hoax, and will bring further dispute to plant genetic engineering where public relations exercises seem to have replaced science in promotion of untested, unproven and unnecessary technology."

"The problem is that vitamin A rice will not remove vitamin A deficiency (VAD). It will seriously aggravate it. It is a technology that fails in its promise.

Since the daily average requirement of vitamin A is 750 micrograms of vitamin A and 1 serving contains 30g of rice according to dry weight basis, vitamin A rice would only provide 9.9 micrograms which is 1.32% of the required allowance. Even taking the 100g figure of daily consumption of rice used in the technology transfer paper would only provide 4.4% of the RDA."

"In order to meet the full needs of 750 micrograms of vitamin A from rice, an adult would have to consume 2 kg 272g of rice per day. This implies that one family member would consume the entire family ration of 10 kg. from the PDS in 4 days to meet vitaminA needs through "Golden rice".

"This is a recipe for creating hunger and malnutrition, not solving it."

"Even the World Bank has admitted that rediscovering and use of local plants and conservation of vitamin A rich green leafy vegetables and fruits have dramatically reduced VAD threatened children over the past 20 years in very cheap and efficient ways."
See: THE "GOLDEN RICE" HOAX -When Public Relations replaces Science
http://online.sfsu.edu/~rone/GEessays/goldenricehoax.html



The ISIS report calls the Tufts experiments "morally inexcusable:"

"The phase II clinical trials of uncharacterized, unapproved, experimental GR2 events on children, some of whom may indeed be suffering from vitamin A deficiency, is morally inexcusable. GR2 has not been assessed for safety, and there are reasons to suspect it is unsafe."
See: http://www.i-sis.org.uk/goldenRiceScandal.php



In February, 2009, an open letter addressed to Professor Robert Russell, Professor Emeritus, Friedman School of Nutrition Science and Policy, Tufts University School of Medicine (Email: rob.russell@tufts.edu) was signed by 30 senior scientists who protested the unethical testing of a possibly hazardous substance--"Golden Rice" (GR2) in children.

The letter states that the trials

"appear to be an experimental collection of transgenic events still in the laboratory, uncharacterized in terms of basic molecular genetics or biological and biochemical properties, not tested pre-clinically on animals, or subjected to any other safety assessment."

"The variety of Golden Rice used in these experiments (GR2) is inadequately described in terms of biological and biochemical characterization. anywhere else in the publicly available literature, and has woefully inadequate pre-clinical evaluation."

" It is a genetically modified product which has not been shown to be distinctive, uniform and stable over time. It has never been through a regulatory /approvals process anywhere in the world. There is now a large body of evidence that shows that GM crop/food production is highly prone to inadvertent and unpredictable pleiotropic effects, which can result in health damaging effects when GM food products are fed to animals (for reviews see Pusztai and Bardocz , 2006; Schubert, 2008; Dona and
Arvanitoyannis, 2009)."

"More specifically, our greatest concern is that this rice, which is engineered to overproduce beta carotene, has never been tested in animals, and there is an extensive medical literature showing that retinoids that can be derived from beta carotene are both toxic and cause birth defects."

No results have been made available for either of the pediatric studies (as of 17 March 2009).

The scientists noted that the three Tufts Projects breached the Nuremberg Code / medical ethics code "on a number of counts, and we urge you to call them to a halt immediately."

"They should not be resumed unless and until the researchers can demonstrate that a full range of laboratory and animal feeding trials have been completed and published for the Golden Rice strain being used, and unless and until appropriate regulatory bodies have had an opportunity to come to a view on the health and safety issues about which we are very concerned."

"We can assure you that such trials would not have been approved within the European Union in the absence of safety information, which highlights yet again the flaw of the USDA and FDA regulatory system in considering GM crops/foods as hypothetically "generally recognised as safe - GRAS" in the
absence of hard experimental data."

Further underscoring the U.S. academics' and government agency disregard for medical ethics, the ISIS report notes that an Indian newspaper reported that a clinical trial was cut short in China in July 2008, when the government found that 24 children 6-8 years of age at a primary school in Henyan, Hunan, were to be used as guinea pigs for a trial with Golden Rice."

That trial was also sponsored by Tufts University and approved by the US National Institute of Health--though not from the Chinese government, which was alerted by Greenpeace. Greenpeace has also warned the governments of Bangladesh, India, Indonesia, Philippines and Vietnam against the risky trials.

It would appear that the Chinese government conforms to higher medical ethics standards than the US National Institute of Health.

So, why has the media failed to pay any attention to these morally deplorable human experiments on American children ?

Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974

http://www.i-sis.org.uk/goldenRiceScandal.php


ISIS Report 18/03/09

The Golden Rice Scandal Unfolds

Phase II clinical trials on children have been conducted with unapproved experimental GM rice enhanced in pro-Vitamin A that has the potential to cause birth defects and developmental abnormalities Dr. Mae-Wan Ho and Prof. Joe Cummins

This report has been sent to the United States Food and Drug Administration on behalf of ISIS

Clinical trials of unapproved, uncharacterized GM rice on children

EXCERPT:
According to a recent report [9], a sample of the Golden Rice grains was sent to Germany in 2001 for a feeding trial with mice. But when the grains were tested for carotenoid content, the scientists were "surprised to find it contained less than one percent of the amount expected." After the rice was cooked, this was reduced by another 50 percent, so the trial was abandoned.

In 2005, Syngenta made GR2 [10] using the maize version of the enzyme phytoene synthase that was transferred from daffodil. GR2 produced up to 23 times the amount of carotenoids in the original Golden Rice, GR1.

But GR2 was not a transgenic variety based on a single transformation event.  On the contrary, it was explicitly stated that [10]: "The reported transgenic rice events [emphasis added] are experimental." There is no telling whether all the children or adults taking part in any of the trials
were given Golden Rice from the same GR2 event.  The results of the trials, as yet unreleased, could well be utterly worthless.

Syngenta was donating these GR2 events, via the Humanitarian Project for Golden Rice, for further research and development (to institutes across China, India, Philippines, Indonesia, Bangladesh and Vietnam) "through license under certain conditions", which include "being governed by the
strategic direction of the Golden Rice Humanitarian Board" Requests were to be directed to Adrian Dubock, a previous employee of Syngenta.

Dubock helped Potrykus and Beyer work out a deal in which Syngenta could develop Golden Rice commercially, but farmers in developing countries who make less than US$10 000 a year could get it for free [5]. Dubock retired from Syngenta in 2007, but remains a member of the Golden Rice Humanitarian Board, chaired by Potykus.

Golden Rice, an exercise in how not to do science

Golden Rice, genetically modified to make pro-vitamin A in the endosperm (the grain remaining after polishing), was announced with great fanfare in 2000 as a cure for widespread vitamin A deficiency in developing countries.

The project had already cost US$100 million, funded by the Rockefeller Foundation, the Swiss Federal Institute of Technology, the European Community Biotech Programme and the Swiss Federal Office for Education and Science, and could cost as much again to develop. It was tied up in at least 70 patent claims on genes, DNA sequences and constructs, a problem only partly solved in the "ground-breaking deal" worked out by Dubock (see above)..

Condemnation was swift and widespread, not least because it was absurd to offer Golden Rice as the cure for vitamin A deficiency when there are plenty of alternative, infinitely cheaper sources of vitamin A or pro-Vitamin A, such as green vegetables and unpolished coloured rice (especially black and purple varieties [11], which would be rich in other essential vitamins and minerals, and hence much more nutritious. The UN Food and Agricultural Organization (FAO) started a project in 1985 to deal with vitamin A deficiency using a combination of food fortification, food supplements and general improvements in diets by encouraging people to grow and eat a variety of green leafy vegetables. One main discovery from the project was that the absorption of pro-vitamin A depends on the overall nutritional status, which in turn depends on the diversity of the food consumed [12].

The main cause of hunger and malnutrition in the Third World is the industrial monocultures of the Green Revolution, which obliterated agricultural biodiversity and soil fertility, resulting in ever-worsening mineral and micronutrient deficiencies in our food. Golden Rice, like other GM crops, is industrial monoculture only worse, and will exacerbate this trend, as well as the destruction of agricultural land, and the impoverishment of family farmers that also accompanied the Green Revolution [13] (see Beware the New "Doubly Green Revolution", SiS 37).

GR1 was made with the standard 'first generation' genetic modification techniques, using GM constructs that cause uncontrollable mutations and other collateral damage to the host plant genome, with many unintended, uncharacterized effects [14]. In addition, the viral and bacterial sequences, including antibiotic resistance marker genes, in the construct and in the vectors created for gene transfer enhance horizontal gene transfer and recombination, the main route to creating new pathogens and spreading antibiotic resistance.

GR2 represents an improvement in so far as antibiotic resistance markers were no longer used, but still includes a medley combination of sequences\ from plant pathogens Agrobacterium (used in a binary vector system) and Erwinia uredovor, and from E. coli, inhabitant of the human gut, which also contains pathogenic strains. We have highlighted the special hazards of the Agrobacterium vector system since 2003 [15] (Agrobacterium & Morgellons Disease, A GM Connection?, SiS 38) (see below).  The main reason for Golden Rice was revealed in the unusually long news feature article [16] accompanying the scientific publication [8] which stated: "One can only hope that this application of plant genetic engineering to ameliorate human misery without regard to short-term profit will restore this technology to political acceptability."

A detailed audit on the project [14] (The 'Golden Rice', An Exercise in How Not to Do Science, ISIS Report) uncovered "fundamental deficiencies" from the scientific and social rationale to the science and technology involved.  It was being promoted "to salvage a morally as well as financially bankrupt agricultural biotech industry." The situation has changed little since.

The phase II clinical trials of uncharacterized, unapproved, experimental GR2 events on children, some of whom may indeed be suffering from vitamin A deficiency, is morally inexcusable. GR2 has not been assessed for safety, and there are reasons to suspect it is unsafe.  GMO safety in question

The biotech industry has consistently found genetically modified food and feed 'as safe as their conventional counterparts', and regulators in the United States and European Union have accepted this assertion overwhelmingly based on studies carried out and interpreted by the industry [17] (GM Food Nightmare Unfolding in the Regulatory Sham, ISIS scientific publication).

There is now a string of evidence that exposure of many species of animals to a variety of genetically modified crops, and food and feed derived from them, can cause illnesses and death, raising the distinct possibility that genetic modification is inherently dangerous [18] (GM is Dangerous and Futile, SiS 40). This is reinforced in results obtained in the most recent studies.
....
Golden Rice particularly dangerous

In addition, the unbalanced enhancement of single nutrients in GM crops may do more harm than good [27] (GM Crops and Microbes for Health or Public Health Hazards? SiS 32). As David Schubert at the Salk Institute for Biological Sciences La Jolla, California, in the United States points out [28], plants possess the ability to synthesize between 90,000 and 200,000 nonessential small molecules, with up to 500 in one species. The enormous repertoire is due in part to enzymes with very low substrate specificity, which are unpredictably altered by mutations and pleiotropic effects associated with GM technology. Furthermore, overdose of many single nutrients are known to be toxic, vitamin A being a case in point. Schubert highlights the toxic effects of retinoic acid and other metabolites of b-carotene, only a few of them can be identified and measured in the current state of technology.

Golden Rice is enhanced in b-carotene, which on ingestion, is cleaved in half to generate retinal for use in the visual cycle. Retinal is also reduced to retinol, or oxidized to retinoic acid (RA), which interacts with highly specific nuclear receptors. Essentially all of the biological activity of retinoids, apart from vision, involves RA. While high concentrations of retinol are toxic, RA is biologically active at concentrations several orders of magnitude lower than retinol. Hence, Schubert states [28]: "excess RA or RA derivatives are exceedingly dangerous, particularly to infants and during pregnancy." RA is required for the development of the nervous system, both by directly controlling nerve differentiation and by generating concentration gradients that direct cell migration, embryonic segmentation, and development. Therefore, RA and synthetic derivative of RA are teratogenic (able to cause birth defects).  They can accumulate in fat and plasma, becoming a risk factor for pregnancy for up to 2 years following ingestion, and multiple low doses of retinoids have greater toxicity than a single high dose.

Because of the type of biological functions controlled by low levels of RA, any perturbation of its signalling pathways by plant-derived RA receptor agonists or antagonists will have clinical consequences. "Could the GM modifications used to enhance b-carotene synthesis create such compounds?"
(This question remains unanswered to this day.) Six hundred naturally occurring compounds exist in the carotene family, and at least 60 can be precursors to retinoids. "Therefore, plants have the potential to make many potentially harmful retinoid-like compounds when there are increased levels of synthetic intermediates to b-carotene as in golden rice."

While all retinoids and derivatives are likely to be teratogenic, good assays and information regarding the behaviour and teralogic activity are available for only three: retinol, RA, and retinal. Therefore, at the very least, "extensive safety testing should be required before the introduction of golden rice as a food."

See complete ISIS report with copious references at:
http://www.i-sis.org.uk/goldenRiceScandal.php



FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.

Labels: bioethics, Chinese, Chinese medicine, COI, ethics, medical, medicine, research, science

Detached Early Cancer Cells May Die from Lack of Nourishment Antioxidants Could Rescue Starving Tumors-to-be Cells don’t like to be alone. In the early stages of tumor formation, a cell might be pushed out of its normal environment due to excessive growth. But a cell usually responds to this homeless state by dismantling its nucleus, packing up its DNA, and offering itself to be eaten by immune cells. Simply put, the homeless cell kills itself. This process, known as apoptosis, typically stops potential cancer cells before they have a chance to proliferate. Photo by Liza Green, HMS Media Services Joan Brugge and collaborators have identified metabolic defects with a lethal effect on cells that stray too far from their home environment. The defects might be a way for the body to stop potential tumor cells from proliferating. Now, researchers from the lab of Joan Brugge, the Louise Foote Pfeiffer professor of cell biology and chair of that department, have discovered another mechanism that these precancerous, homeless cells use to commit suicide. By studying two different types of human breast epithelial cells, the researchers found that when separated from their natural environment, these cells lose their ability to harvest energy from their surroundings. Eventually, they starve. “We originally thought that in order for cells to survive outside their normal environment, they would simply need to suppress apoptosis,” said Brugge, senior author on the paper, which appeared online Aug. 19 in Nature. “But our studies indicate that this activity is not sufficient to prevent the demise of homeless cells. Even if they escape apoptosis, these cells can’t transport enough glucose to sustain an energy supply.” Surprisingly, metabolic function is restored if antioxidant activity is increased inside the cells, allowing them to use energy pathways that do not rely on glucose. “It raises the interesting idea that antioxidants, which are typically thought to be protective because they prevent genomic damage, might be allowing these potentially dangerous cells to survive,” said first author Zachary Schafer, assistant professor at the University of Notre Dame and a former postdoc in Brugge’s lab. “It raises the interesting idea that antioxidants, which are typically thought to be protective because they prevent genomic damage, might be allowing these potentially dangerous cells to survive.” —Zachary Schafer The authors caution against extrapolating too far from their data, which were based on cell culture. They also emphasize that the experiments were not designed to mimic the effect of dietary antioxidants. The researchers used two specific antioxidant compounds—chemically distinct from those found in food and supplements—only to understand how oxidants contribute to the metabolic defects. “We think that genes with antioxidant activity play a much bigger role than antioxidant compounds administered from outside the body,” said Brugge. Beyond Cell Suicide The team had previously reported that when cells were endowed with a cancer-causing gene that prevents them from committing suicide, they still died when cut off from their extracellular environment. This puzzled the researchers since they had long thought that apoptosis was the only way the cells could die. In the recent study, Schafer and colleagues took a closer look, measuring the levels of proteins and molecules associated with metabolic activity in the displaced, but apoptosis-resistant, cells. They found that the cells had become incapable of taking up glucose, their primary energy source. Under the microscope, the cells also displayed telltale signs of oxidative stress, a harmful accumulation of oxygen-derived molecules called reactive oxygen species (ROS). The result was a halt in the production of ATP, the molecular lifeblood that transports energy in the cells. The unmoored cells were literally starving to death. “The idea that a lack of extracellular matrix can prevent cells from accessing nutrients hasn’t been shown conclusively before,” said Schafer. “Loss of glucose transport, decreased ATP production, increased oxidative stress—all those things turn out to be interrelated.” Tumor Metabolism To figure out what was wrong, the researchers took a direct approach: they tried to fix it. Schafer engineered the homeless cells to express high levels of a gene, HER2, known to be hyperactive in many breast tumors. He also treated the cells with antioxidants in an attempt to relieve oxidative stress and help the cells survive. Both strategies worked. The cells with the breast cancer gene regained glucose transport, preventing ROS accumulation, and recovered their ATP levels. The antioxidant-treated cells also survived, but by using fatty acids instead of glucose as an energy source. 10A 10A Trolox Courtesy Zachary Schafer In these microscope images, human mammary cells (blue) grow in clusters surrounded by a membrane of extracellular matrix (red), which usually keeps them alive. Normally (left), the cells in the middle of the cluster die due to lack of contact with the extracellular matrix, leaving an empty space. In cells treated with Trolox (right), an antioxidant derived from Vitamin E, cells separated from the extracellular matrix survive, filling up the middle of the cluster. “Our results raise the possibility that antioxidant activity might allow early-stage tumor cells to survive where they otherwise would die from these metabolic defects,” said Schafer. The researchers are currently planning to test the effects of antioxidant genes, some of which are abnormally regulated in human tumors, and a wider range of antioxidants in animal models. They also plan on characterizing the metabolic consequences of matrix detachment in more detail. “Ultimately,” Brugge said, “we want to understand enough about the metabolism of tumor cells so that new types of drugs can be designed to target them.” —Jue Wang Students may contact Joan Brugge at joan_brugge@hms.harvard.edu for more information. Conflict Disclosure: The authors declare no conflict of interest. Funding Sources: The National Cancer Institute and the National Institutes of Health; the authors are solely responsible for the content of this work. top

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Why doctors should inform their patients where the medicines comes from

Labels: behavior, behaviormod, bioethics, budget, costs, disease, disease management, economics, economy, ethics, government, health, healthcare, medical, medicine, prevention, purity, vegan, vegetarian

Forget Who Pays Medical Bills,
It’s Who Sets the Cost
(and it's not preventing any problems, anyway!)

By DAVID LEONHARDT Published: July 25, 2009

Related
Political Memo: Partisan or Not, a Tough Course on Health Care (July 26, 2009)
Obama Defends Proposed Health Office (July 26, 2009)
Obama Moves to Reclaim the Debate on Health Care (July 23, 2009)
Times Topics: Health Care Reform

WASHINGTON — Every fight over health care reform is different, and every fight over health care reform is the same.

In 1929, Michael Shadid, a doctor in western Oklahoma, proposed an idea for making medical care affordable to farmers. Rather than pay piecemeal for treatments, farmers would each contribute $50 a year to a cooperative. Dr. Shadid and his colleagues would pay their own salaries and expenses with the aggregate sum, and no farmer’s annual bill for family medical care would exceed $50.

Horrified by the plan, other Oklahoma doctors tried to revoke Dr. Shadid’s license. The conflict was soon duplicated across the country; cooperatives sprang up, and the American Medical Association tried to beat them back. The A.M.A.’s members, as the historian Paul Starr has written, felt threatened because the cooperatives “subjected doctors’ incomes and working conditions to direct control by their clients.”

The issue was clear: Who controls the doctor-patient relationship? That question has been at the core of every big subsequent battle over health care. Should doctors determine not only their patients’ treatment but also their own pay, through the fee-for-service system that has survived since the 1920s? Or should patients have more power in the relationship? And who could claim to act on patients’ behalf, monitoring treatments and bargaining with doctors?

A succession of presidents — from Harry S. Truman to Richard M. Nixon to Bill Clinton — volunteered the government for the role of patients’ advocate, and their grand efforts all failed. Now it is President Obama’s turn to try to remake America’s medical system.

Last week’s back and forth, when Congressional Democrats squabbled and Mr. Obama took his case to the public, highlighted how difficult his task will be. Reform of health care has the potential to threaten profits and incomes that make up one-sixth of the economy. More daunting, perhaps, Americans seem to have great trust in their doctors — more, certainly, than they trust the government on medical matters.

More than three in four Americans are “very satisfied” or “somewhat satisfied” with their own care, according to the latest New York Times/CBS News poll. But a substantial majority also say that the health care system needs fundamental change and that rising costs are a serious threat to the economy — a view that economists strongly share.

Thus the political challenge facing any effort at an overhaul: Americans say they want change, but they also want to preserve their own status quo.

The disconnect can be explained partly by the peculiar economics of health care. Because third parties — the government or a private insurer — typically pay the bill, many people miss the fact that the money originally comes from them. They see the benefits of medical care without seeing the costs.

But trust in doctors is a factor as well. Even when doctors order costly treatments with serious side effects and little evidence of their being effective, as studies find is common, patients are loath to question the decision. Instead of blaming such treatments for the rising cost of medicine, many people are inclined to blame forces that health economists say are far less important, like greedy insurance companies or onerous malpractice laws.

Mr. Obama is well aware of the public perception. This is why he directs his criticism not at doctors but at insurers and drug companies. In his news conference on Wednesday night, he advocated creating a government panel with the power to begin moving Medicare away from its fee-for-service model and emphasize outcomes instead. But he described it in doctor-friendly terms — as “an independent group of doctors and medical experts who are empowered to eliminate waste and inefficiency.”

His rhetorical choices highlight one of the least discussed but most important conflicts in the current health care debate. The fight isn’t just a matter of Democrats vs. Republicans, Blue Dogs vs. liberals or patients vs. insurers. It is also doctors vs. doctors.

That’s the same as in Oklahoma in 1929. And what has happened to Dr. Shadid’s model? It has survived. He built a team of doctors who collaborated closely and were not paid based on how many procedures they performed. Today, this description fits the Mayo Clinic and the Cleveland Clinic (which Mr. Obama visited on Thursday), as well as less-known groups around the country.

Medicare data shows that these groups generally provide less expensive care and appear to deliver better results. Armed with this data, the doctors who run the groups have been lobbying Congress to make their model a bigger part of health reform. Two weeks ago, 13 such groups released a letter saying that recent versions of proposed legislation did not control costs enough.

Their goal is to weaken the fee-for-service system. In its place, doctors might receive a lump-sum payment to treat a patient with a certain condition, based on average costs elsewhere and on what scientific evidence had found to be effective. Hospitals with especially good outcomes might earn bonuses.

Advocates say such a system could ultimately give doctors more control. Rather than having to organize their schedules around the tests and procedures that insurers agree to reimburse, doctors could opt for the treatments they deem most effective. “It’s a lot more accountability, which is why it’s scary for physicians,” said Dr. Mark McClellan, a former head of Medicare under George W. Bush. “But in some ways it’s also more autonomy.”

On Tuesday, doctors and hospital executives from 10 cities with below-average cost growth gathered in Washington for a conference called, “How Do They Do That?” They were a diverse lot, only some of whom hailed from providers resembling the Mayo Clinic. While crediting a range of factors for their success, they generally agreed about what ails American medicine.

When Dr. McClellan, who helped organize the conference, asked how many people thought the fee-for-service system was “archaic and fundamentally at odds” with good practice, most hands shot up. In effect, they were siding with Dr. Shadid and against a system that provides incentives for more and more care, regardless of its benefit.

“There are no consequences right now to over-utilization,” Dr. Anthony F. Oliva, chief medical officer of the Guthrie Healthcare System, in northeast Pennsylvania, said later. “If you don’t have consequences, you won’t change the culture. If you don’t have consequences, the people that are killing themselves to control cost are going to say, ‘Why am I doing this?’”

It is a message, of course, that a doctor can deliver more easily than anyone else.

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