“Gleevec can cost up $70,000 per year, while Indian generic versions cost about $2,500 a year.”

Clarísimo.

Indian Supreme Court Delivers Verdict in Novartis Case

Decision safeguards access to affordable medicines and prevents abusive patenting of medicines

vía Indian Supreme Court Delivers Verdict in Novartis Case | msfaccess.org.

vía Oferta 2013 Cursos de Perfeccionamiento @ Facultad de Ciencias Sociales | UBAFacultad de Ciencias Sociales | UBA.

Letter from 26 University Entomologists to EPA (2008)

The following statement has been submitted by 26 leading corn insect scientists working at public research institutions located in 16 corn producing states. All of the scientists have been active participants of the Regional Research Project NCCC-46 “Development, Optimization, and Delivery of Management Strategies for Rootworms and Other Below-ground Insect Pests of Maize” and/or related projects with corn insect pests. The names of the scientists have been withheld because virtually all of us require cooperation from industry at some level to conduct our research.

Statement:

“Technology/stewardship agreements required for the purchase of genetically modified seed explicitly prohibit research. These agreements inhibit public scientists from pursuing their mandated role on behalf of the public good unless the research is approved by industry. As a result of restricted access, no truly independent research can be legally conducted on many critical questions regarding the technology, its performance, its management implications, IRM, and its interactions with insect biology. Consequently, data flowing to an EPA Scientific Advisory Panel from the public sector is unduly limited.”

Don M. Huber, Professor Emeritus of Purdue University writes a letter to Vilsack regarding his concerns about glyphosate.

This cover letter is provided to explain the reasoning and concerns that were conveyed in a letter which I sent to Secretary of Agriculture, Thomas Vilsack on January 17, 2011 (Attachment 1). The letter was not intended for public distribution; however, the letter was ‘leaked’ and subsequently posted on the internet from which it soon became public knowledge world-wide. Once it was widely distributed, I gave permission for subsequent postings in order to keep it consistent. My busy meeting and travel schedule has delayed getting further information on this matter out publicly to the many individuals who have requested it. The scientific data on this newly recognized organism is being prepared for formal publication.

I wrote the letter to Secretary Vilsack for a very simple reason: we are experiencing a large number of problems in production agriculture in the U.S. that appear to be intensified and sometimes directly related to genetically engineered (GMO) crops, and/or the products they were engineered to tolerate – especially those related to glyphosate (the active chemical in Roundup® herbicide and generic versions of this herbicide). We have witnessed a deterioration in the plant health of corn, soybean, wheat and other crops recently with unexplained epidemics of sudden death syndrome of soybean (SDS), Goss’ wilt of corn, and take-all of small grain crops the last two years. At the same time, there has been an increasing frequency of previously unexplained animal (cattle, pig, horse, poultry) infertility and spontaneous abortions. These situations are threatening the economic viability of both crop and animal producers.

Incidence of high infertility and spontaneous abortions in the various animal species is becoming more common. Often, all previously known causes of these conditions can be ruled out as factors for these particular farm operations (Attachment 2). Detailed examination for the newly recognized organism has shown its presence in all of the cases examined to date. Koch’s postulates have been completed for animals to verify the cause/effect relationship with this newly culturable organism. A search for the source of animal infections revealed a high population of this newly discovered electron microscopic sized organism in soybean meal and corn products. The organism appears compatible, and probably synergistic, with other microorganisms such as Fusarium solani fsp. glycines, the cause of SDS of soybeans and also with gram positive bacteria. The organism also is in a very high population in Goss’ wilt infected corn caused by the gram positive bacterium Clavibacter michiganensis subsp. nebraskensis.

Although most corn hybrids have been genetically resistant to Goss’ wilt, preliminary research in 2010 demonstrated that the application of glyphosate herbicide, or the surfactant from glyphosate formulations, nullified this resistance and rendered them fully susceptible to this pathogen (Fig. 1). This disease was commonly observed in many Midwestern U.S. fields planted to RR corn in 2009 and 2010, while adjacent non-GMO corn had very light to no infections in spite of the high inoculum present in no-till crop residues (Figure 2). The increased Goss’ wilt in 2010 was a major contributor to the estimated almost one billion bushels of corn ‘lost’ last year (based on USDA August estimated yields and actually harvested crop reported by USDA in January) in spite of generally good harvest conditions.

Increased severity of plant diseases after glyphosate is applied (Fig. 3) is well documented and, although rarely cited, the increased disease susceptibility is the herbicidal mode of action of glyphosate (Johal andRahe,1988, 1990; Johal and Huber, 2009; Schafer et al, 2009, 2010). The loss of disease resistance in Roundup Ready® sugar beets when glyphosate was applied prompted researchers at the USDA sugar beet laboratory to include a precautionary statement in their paper, e.g. “Precautions need to be taken when certain soil-borne diseases are present if weed management for sugar beet is to include post-emergence glyphosate treatments” (Larson et al, 2006).

The loss of genetic resistance in Roundup Ready® corn hybrids to Goss’ wilt (Clavibacter michiganensis subsp. nebraskensis) (Figs. 2, 3), synergistic relationship of the newly recognized electron microscopic organism causing infertility and abortions in animals with gram+ bacteria, and high populations of the new EM organism in RR corn leaves and silage creates a concern for the deregulation of Roundup Ready® alfalfa which is productive in many areas only because of its genetic resistance to bacterial wilt caused by Clavibacter michiganensis subsp. insidiosum. This disease could make alfalfa unprofitable for production and, if the EM organism is associated with it in alfalfa as it is in corn, also unsafe for animal feed and their products such as milk for human consumption. The loss of alfalfa, the United State’s most valuable forage crop and fourth most economically important crop, could strike a mortal blow to struggling dairy and beef operations.

Extensive research has shown that this potent tool for weed management, glyphosate, is also a strong immobilizer (chelator) of essential plant nutrients to impair nutrient uptake, translocation, and physiological efficiency at only a fraction of the labeled herbicidal rate (Ekers, Ozturk, Cakmak, Zobiole, Jolly et al., 2004). Glyphosate is a powerful biocide to harm beneficial soil organisms important for nutrient recycling, N-fixation, nutrient availability, and natural disease control (Kremer & Means, Zobiole et al, Dick et al) with a resultant increase in diseases of corn, soybeans (Fig. 3), wheat and other crops. The close relationship between mineral nutrition and disease severity is well documented (Datnoff et al, 2007). These activities can have deleterious effects on plant nutrition, disease susceptibility, and nutritional quality of the crop produced.

Deleterious effects of GM crops also are vividly demonstrated in reports from livestock producers in the U.S. Although some of these reports are anecdotal because of limited analytical techniques to verify the cause, some producers have been able to resume economical operations by changing feed sources to non-GMO crops. Replicated independent research is needed in this area, especially in light of the serious toxicological concerns raised recently that show potential human and animal toxicity from very low levels of residual glyphosate in food/feed that are many times lower than permitted in U.S. food and feed products (Seralini et al., 2011). The recent Indian Supreme Court’s independent analysis and Ruling that GMO egg plant posed a significant health risk to humans needs further evaluation in the U.S. (AgroNews, 2011).

I feel I would be totally irresponsible to ignore my own research and the vast amount of published research now available that support the concerns we are seeing in production agriculture, without bringing it to the attention of the Secretary of Agriculture with a request for him to initiate the much needed independent research. Many producers can’t wait an additional 3-10 years for someone to find the funds and neutral environment to conduct such critical research (Attachment 2. Entomologists letter to EPA).

Based on the scientific evidence currently accumulating, I do not believe it is in the best interests of the agricultural producer or consuming public for regulatory agencies to approve more GMO crops, particularly Roundup Ready® alfalfa and sugar beets, until independent research can establish their productivity when predisposed to potentially severe diseases, the irrelevance of the new EM organism, and their nutritional equivalency. In my letter, I asked the Secretary to allocate the necessary resources to do this, and requested that he exercise the utmost caution in deregulating these crops until such findings resolve the concerns expressed in the letter, if they do.

Don M. Huber

Professor Emeritus, Purdue University                                  17/1/2011

Ver bibliografía en el link al texto original.

Esta entrevista es del 2009, pero cobra actualidad y urgencia con la publicación de

Séralini, G.-E., et al. Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize. Food Chem. Toxicol. (2012)

ABSTRACT – The health effects of a Roundup-tolerant genetically modified maize (from 11% in the diet), cultivated with or without Roundup, and Roundup alone (from 0.1 ppb in water), were studied 2 years in rats. In females, all treated groups died 2–3 times more than controls, and more rapidly. This difference was visible in 3 male groups fed GMOs. All results were hormone and sex dependent, and the pathological profiles were comparable. Females developed large mammary tumors almost always more often than and before controls, the pituitary was the second most disabled organ; the sex hormonal balance was modified by GMO and Roundup treatments. In treated males, liver congestions and necrosis were 2.5–5.5 times higher. This pathology was confirmed by optic and transmission electron microscopy. Marked and severe kidney nephropathies were also generally 1.3–2.3 greater. Males presented 4 times more large palpable tumors than controls which occurred up to 600 days earlier. Biochemistry data confirmed very significant kidney chronic deficiencies; for all treatments and both sexes, 76% of the altered parameters were kidney related. These results can be explained by the non linear endocrine-disrupting effects of Roundup, but also by the overexpression of the transgene in the GMO and its metabolic consequences.

Entre las conclusiones se afirma que “The results of the study presented here clearly demonstrate that lower levels of complete agricultural glyphosate herbicide formulations, at concentrations well below officially set safety limits, induce severe hormone-dependent mammary, hepatic and kidney disturbances.”

“Other mutagenic and metabolic effects of the edible GMO cannot be excluded. This will be the subject of future studies, including transgene and glyphosate presence in rat tissues. Reproductive and multigenerational studies will also provide novel insights into these problems. This study represents the first detailed documentation of long-term deleterious effects arising from the consumption of a GM R-tolerant maize and of R, the most used herbicide worldwide.”

Hace muchos años que Séralini viene estudiando estos temas, y ha denunciado claramente que las semilleras no dan los datos de sus estudios al conocimiento público, los consideran confidenciales. Además tratan de bloquear la investigación.  Por supuesto que gran cantidad de científicos objetan sus conclusiones, pero así se genera la ciencia. De todos modos es imprescindible recordar la necesidad de aplicar el principio de precaución.

¿Como es posible que el Ministerio de Salud argentino no haya establecido un grupo permanente de investigación sobre estos temas de contaminación por plaguicidas y salud pública? ¿Como es posible que trabajos como el que se hizo en la Sardá sobre clorados en leche materna no hayan podido completarse adecuadamente por falta de fondos para reactivos, ni hayan podido tener un seguimiento adecuado de la maduración neurológica de los niños involucrados?

BMJ 2013;346:f755

Editorial del British Medical Journal que dice, entre otras cuantas cosas:

“nine of the 10 largest drug companies were bound by corporate integrity agreements under civil and criminal settlements or judgments in the United States. The corporate activity that has led to recent government investigations has involved unethical and unlawful practices that are well beyond mere administrative offences.
Whistleblowers’ and other “insider” accounts in the US typically include allegations that companies systematically planned complex marketing campaigns to increase drug sales, which involved illegal and fraudulent activities. These included active promotion of off label, or otherwise inappropriate, use of drugs, despite company knowledge that such use could seriously harm patients. “

Al referirse a la falta de medidas de castigo de gravedad apropiada el BMJ dice: “Such timid regulatory behaviour may be symptomatic of the extent to which regulators have been encouraged by governments to be responsive to the commercial interests of industry and to view large drug firms as clients whose fees increasingly fund these agencies.”

Este es el funesto efecto de los PDUFA, que colocan al zorro en el gallinero.

Ver Wikipedia “The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.”

Esta gente -bioeticistas de USA y Europa – pretende pontificar sobre corrupción, y darnos clase, cuando tiene la corrupción instalada hasta los huesos del sistema, y además legalizada, tal como lo denuncia el BMJ.

Sin ruborizarse afirman: “Dr. Ben Goldacre’s book Bad Pharma provides a one-sided and factually questionable view of the clinical trial process led by the innovative biopharmaceutical sector. The book ignores that the current clinical trial system, which is essential to the development of new medicines that save and improve lives, is scientifically rigorous, tightly regulated and working well.”

Al final manifiestan en un recuadrito:

“The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives.”

O sea que estábamos errados, no lo hacen con fines de lucro.

vía Annals of Internal Medicine | SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials.

Para leer con detenimiento.

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.