The number of scientists who have signed onto a statement challenging the safety of genetically modified organisms (GMOs) has climbed to more than 230 today.
The list is expected to continue growing as more scientists are given the opportunity to weigh in on the safety of the organisms, which were quietly introduced into the US food supply in the late 1990s with no labeling requirement.
One new signature on the list in particular stands out: Dr. Belinda Martineau, a former member of the Michelmore Lab at the University of California Davis Genome Center, who helped commercialize the world’s first GMO whole food, the Flavr Savr tomato.
Dr. Martineau issued a statement along with her signature:
"I wholeheartedly support this thorough, thoughtful and professional statement describing the lack of scientific consensus on the safety of genetically engineered (GM/GE) crops and other GM/GE organisms (also referred to as GMOs). Society's debate over how best to utilize the powerful technology of genetic engineering is clearly not over. For its supporters to assume it is, is little more than wishful thinking.”
The U.S. Supreme Court issued a unanimous decision Thursday morning saying that biotech companies and pharmaceutical manufacturers cannot patent configurations of Deoxyribonucleic Acid, also known as DNA.
AbbVie (recently split off from Abbott Laboratories), maker of Humira, and InterMune, maker of Esbriet, have filed a lawsuit against the European Medicines Agency (the European equivalent of the FDA) to block access to clinical trial data on the benefits and harms of their drugs, claiming that these vital facts are “trade secrets” whose release would harm their profits. Medical researches have been denied to clinical trial information.
Of course, when a drug causes cancer, release of clinical data information could potentially harm the profits of the company that makes it. Humira, a drug that is quickly becoming one of the best-selling drugs in the world, mainly because of the marketing techniques used by AbbVie, causes cancer.
The FDA warning label on Humira warns of increased risk of “Lymphoma and other malignancies” including “a rare type of cancer called hepatosplenic T-cell lymphoma” that “often results in death,” along with “increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.”
Clinical trials will always be an essential part of medical research and new drug development. As competition for new medical interventions grows, so does the number of trials. There are currently some 150,000 studies taking place worldwide.
For pharmaceutical companies, the cost of clinical trials is significant. According to EFPIA, clinical studies represent approximately 60% of a product’s total development costs, with challenges around patient recruitment constituting a large proportion of this cost. Thousands of volunteers are required for each study and time taken to enrol is on the critical path of all trials. Enrolment is inevitably slower than planned and uptake low. Studies suggest that less than 5% of adults with cancer, for example, would participate in a study. In addition, the drop-out rate is high, with the British Medical Journal reporting non-completion rates up to 20%. Because of this, finding, targeting and keeping the required number of patients can delay a new product’s time-to-market by months, which represents revenue-loss running to tens of millions of dollars.
Social intelligence offers a fast and inexpensive way to increase patient participation in trials.
Through sophisticated analysis of the online activity of billions of social media users, clinical study sponsors can find the patients they need to take part in trials – and at a much lower cost than traditional methods. Furthermore, by developing a better understanding of what motivates the patients, they can be influenced to participate without contravening ethical standards.
Finding the right patients
Recently we worked with the Medical Research Network, a specialist clinical consultancy, to help a global biopharmaceutical firm design an effective recruitment strategy. Recruitment was falling behind in the programme and for commercial reasons there was a real need to recruit patients fast – within five weeks.
Using PA’s social intelligence methodology, we analysed the vast quantity of social media data – over 170 billion online conversations linked to the study indication – and then filtered and segmented the information to get a picture of the potential patient base. To meet the exact protocol requirements, we also researched how the data linked the indication to multiple factors – such as pre-existing medical conditions, concomitant treatment, etc. We were able to provide a global estimate of 120 million potential patients, broken down by country.
Motivating patients to come forward
After identifying the patient hotspots, we needed to encourage patients to apply to take part in the trial. Since approaching the patients directly would be time-consuming, and would potentially make them uncomfortable, we sought instead to find out which sites influenced them, and ensured that the study details were visible on these channels.
Our analysis revealed that these 120 million patients were most strongly influenced by just 10 key influencers, who were most active on Twitter. It was therefore relatively straightforward to approach these influencers and publicise the clinical trials.
Enriching the trial
Due to its high accuracy, social intelligence can be used to define very specifically the health profile of potential trial patients. In turn, this can provide valuable insight into the efficacy of a study drug within the different patient profile groups. You can, for example, use social intelligence to determine whether potential patients suffer from concomitant diseases or other issues – such as HIV or drug addiction – and then use this information to understand when and how the approved drug should best be prescribed.
Maintaining ethical standards
Using only consented and publicly available data, social intelligence does not contravene the correct ethical approach to recruiting patients. It does not misuse confidential information and does not jeopardise the privacy of individual patients. After we developed the findings of our recent work, we then worked with the ethics committee to produce the recruitment document in the approved process.
The detailed and sophisticated searching that social intelligence offers allows clinical study sponsors to find a higher density of potential trial participants than by other means. And while effective recruitment of patients will always be an issue in the clinical research process, there is no reason why patients should remain unaware and unmotivated to take part when there are new ways to reach out to them. As more and more people use social media as part of their daily lives – especially as a key way to find and share information about their health – social intelligence will only grow in effectiveness.
Animal rights activists in Germany are contesting three patents on genetically engineered chimpanzees granted this year by the European Patent Office (EPO) in Munich. One of the challenges was filed today; the other two will follow shortly, says Ruth Tippe, a spokesperson for a German advocacy group called No Patents on Life...
Patent number EP1456346 was granted to Intrexon, a company based in Blacksburg, Virginia, in February. In it, the company claims to have invented a way to introduce into chimpanzees—as well as rats, rabbits, horses, and other animals—a system to switch specific genes on or off. The animals are intended for pharmaceutical research...
Hypoxia is a major driving force in vascularization and vascular remodeling. Pharmacological inhibition of prolyl hydroxylases (PHDs) leads to an oxygen-independent and long-lasting activation of hypoxia-inducible factors (HIFs). Whereas effects of HIF-stabilization on transcriptional responses have been thoroughly investigated in endothelial cells, the molecular details of cytoskeletal changes elicited by PHD-inhibition remain largely unknown. To investigate this important aspect of PHD-inhibition, we used a spheroid-on-matrix cell culture model.
Microvascular endothelial cells (glEND.2) were organized into spheroids. Migration of cells from the spheroids was quantified and analyzed by immunocytochemistry. The PHD inhibitor dimethyloxalyl glycine (DMOG) induced F-actin stress fiber formation in migrating cells, but only weakly affected microvascular endothelial cells firmly attached in a monolayer. Compared to control spheroids, the residual spheroids were larger upon PHD inhibition and contained more cells with tight VE-cadherin positive cell-cell contacts. Morphological alterations were dependent on stabilization of HIF-1alpha and not HIF-2alpha as shown in cells with stable knockdown of HIF-alpha isoforms. DMOG-treated endothelial cells exhibited a reduction of immunoreactive Rac-1 at the migrating front, concomitant with a diminished Rac-1 activity, whereas total Rac-1 protein remained unchanged. Two chemically distinct Rac-1 inhibitors mimicked the effects of DMOG in terms of F-actin fiber formation and orientation, as well as stabilization of residual spheroids. Furthermore, phosphorylation of p21-activated kinase PAK downstream of Rac-1 was reduced by DMOG in a HIF-1alpha-dependent manner. Stabilization of cell-cell contacts associated with decreased Rac-1 activity was also confirmed in human umbilical vein endothelial cells.
Our data demonstrates that PHD inhibition induces HIF-1alpha-dependent cytoskeletal remodeling in endothelial cells, which is mediated essentially by a reduction in Rac-1 signaling.
Although bioweapons have been used in war for many centuries, a recent surge in genetic understanding, as well as a rapid growth in computational power, has allowed genetic engineering to play a larger role in the development of new bioweapons. In the bioweapon industry, genetic engineering can be used to manipulate genes to create new pathogenic characteristics aimed at enhancing the efficacy of the weapon through increased survivability, infectivity, virulence, and drug resistance. While the positive societal implications of improved biotechnology are apparent, the “black biology” of bioweapon development may be one of the gravest threats we will face.
A recent dispatch in The Post from a village in Tanzania foreshadowed stark choices facing Africa in the decades ahead. Journalist Sharon Schmickle, watching young children eagerly await scoops of corn and beans for lunch, described the conflict in Tanzania between those who suffer from food shortages caused by drought and pestilence and those who hold deep suspicions about the genetic engineering of crops, which might help grow more food. The doubters about genetic modifications seem to have the upper hand in Tanzania at the moment, and that is disturbing.
As a new report from the Center for Strategic and International Studies points out, genetic engineering in agriculture is not a magic bullet for Africa, but it can help battle pests and diseases, improve nutrition and reduce the use of water and chemicals, all of which would benefit farmers and their families. Genetically modified crops can increase yields, which lag in Africa behind those of the rest of the world.
African countries and research organizations in the Water Efficient Maize for Africa project, for example, have incorporated a gene from a common soil bacterium into corn, enabling plants to produce kernels even when short of water. The genetically modified corn is expected to increase yields by 25 percent during a moderate drought. Yet this corn is not being tested or planted in Tanzania. The country has adopted some of the most restrictive rules on the continent to govern genetically modified food. A policy of “strict liability” threatens companies or organizations that introduce genetically modified crops, and none has dared to bring such plants to Tanzania’s fields. Scientists are hampered and frustrated.
Africa in general has been slow to accept genetic engineering. Only four nations have commercialized biotech crops: South Africa, Egypt, Sudan and Burkina Faso. Underlying the hesitation... Europe has rejected the crops, and European activists have urged Africa to follow suit. There is much talk of a threat to Africa’s “food sovereignty.” This is having some impact, however misguided.
Smallholder farmers... are the backbone of Africa’s agriculture. They face immense difficulties. Fewer than a third of the farmers in sub-Saharan Africa use any type of improved seeds that have been developed through conventional breeding, let alone more advanced, genetically modified varieties. This is the hard reality that can’t be changed overnight by genetic engineering.
Surely, there is no harm in a vigorous debate about genetically modified food; if people don’t understand it, the benefits will never be realized. But it is a shame to abandon these crops based on irrational fears and suspicions. If Europeans choose to forego genetically modified food, they can do so without risking hunger. They ought not discourage its use for those village children in Tanzania who are hungry and at the mercy of drought.
"There is no way to overstate the importance of this case to the future of science and medicine. In the view of Myriad and its supporters in the biotech and pharmaceutical industries, patents are the keys to making these medical discoveries possible. Their opponents, including leading medical groups and Nobel Prize-winning scientists, contend that Myriad's patent improperly puts a lock on research and medical diagnostic testing.
The U.S. patent system, authorized in the Constitution, gives temporary economic incentives to inventors to advance science. The general rules of the patent system have been established in statutes and Supreme Court case law for over 150 years. You can't patent a product of nature or a law of nature. It doesn't matter that the task was difficult or costly. Nature is immune to patents. So, even though it may have taken Einstein a long time to figure out that E=mc2, he couldn't have patented that law of nature."
The pharmaceutical giant Roche is being accused of irresponsibly withholding key trial data about a vital flu drug on which governments around the world have spent billions of pounds.
Yesterday, the British Medical Journal launched a campaign to persuade Roche to give doctors and patients the full data on Tamiflu, three years after doubts about its safety and efficacy emerged.
In 2009, researchers from the Cochrane Collaboration found that results of eight out of 10 key trials of Tamiflu were never fully published and concluded there was "insufficient data" to show it reduced complications...
Popular Science The Supreme Court's Bad Science on Gene Patents Bloomberg If there were no patent available for gene identification, it would significantly reduce the incentive of big pharmaceutical companies to go after the basic science needed to...
Monsanto's Minion Announces Surrender on GMO Labeling For related articles and more information, please visit OCA's Genetic Engineering page, Millions Against Monsanto page and our Washington News page.
The U.S. pharmaceutical industry and its Big Brother Chamber of Commerce have launched an all-out disinformation campaign against the India Patent Act and decisions rendered thereunder.
They have enlisted allies in the U.S. government, including Members of Congress, the United States International Trade Commission, Secretary of State Kerry, and even President Obama, to carry their claims to the highest levels of the Indian government. They have threatened to insist that the U.S. file a WTO trade complaints against India in 2014 and that India no longer be permitted to export duty-free products to the U.S. under the Generalized System of Preferences.
As evidence for their campaign, the representatives of Big Pharma have claimed that India is violating US-based global norms for protecting patent rights, that it is adopting new patenting criteria not authorized by international law and allowing generic competition when it is not permissible, and that it is discriminating against U.S. pharmaceutical companies in favor protectionist policies that shield Indian generic companies and steal U.S. jobs. Each and every one of these claims is false – and false in multiple ways.
The U.S. cannot unilaterally impose global IP norms binding India
In challenging each of the “dirty dozen” patent cases that U.S. and European pharmaceutical companies have lost in India in the past few years, the U.S. industry makes a background claim that the drugs at issue had been patented in the U.S. and in many other countries and therefore that India’s actions are illegal.
Apparently, Big Pharma wishes that the U.S. could impose its pro-monopoly IP laws on every other country in the world, but in fact international norms are set by the WTO Agreement on Trade-Related Aspects of Intellectual Property (TRIPS). The U.S. and Big Pharma got much of what they wanted in TRIPS in 1994 but not everything. In particular, TRIPS preserved significant general interpretative flexibilities for Member States in Article 1.1 and explicit flexibilities concerning patentable subject matter, applicant disclosure requirements, and standards of patentability in Article 27.
It allows countries to seek a balance between the interests of IP owners and users, allows countries to prioritize public, and promises technology transfer, Article 7 and 8. TRIPS expressly allows limitations and exceptions to IP rights, Article 30; compulsory and government use licenses on any ground whatsoever, Article 31; and use parallel importation of the same goods from other countries where they are sold cheaper, Article 6. TRIPS allows opposition procedures and payments of royalties in lieu of injunctions.
It is simply irrelevant legally whether a particular U.S. pharmaceutical company has received a patent in another country. Countries have flexibilities to enact much more stringent standards for patents than does the U.S. or Europe and that is exactly what India has done.
In particular, it has decided to draw a line in the sand against granting secondary, evergreening patents on minor modification of existing medicines or medical ingredients, on new uses of existing medicines, and on combinations of previously existing substances. India can legally justify this choice either by resort to its definition of patentable subject matter or by its test for inventive step. In fact, India has gone further towards liberalization than it needs to because it provides patent protection for incremental changes when they have a significant therapeutic benefit.
What’s really going on?
U.S. IP industries, including Big Pharma, are salivating to exploit middle- and upper-income consumers and patients in India and in other so-called pharmemerging countries. These are Big Pharma’s regions of expected sales expansion and their new profit centers. U.S. drug companies want to beat back generic competition and secure an uneven playing field where the big boys always win – where the golden goose of innovation always lays huge gleaming eggs for them. To ensure this outcome, the U.S. pharmaceutical industry and its agents will always try to corral and hamstring the Indian generic industry or turn it into its junior partners. If Pharma can’t win fair and square, it will malign generics, usually about quality, and seek to change the law through any means possible.
However, Big Pharma also wants to forestall the emerging trend of other countries copying India-style strict standards of patentability. It’s no surprise that the timing of the Big Pharma disinformation offensive is right around the time that Brazil and South Africa are launching their own patent law reforms, following in the footsteps of India. If Big Pharma and the U.S. can bully India into changing its patent law and making it consistent with U.S. law, then other countries will think thrice before crossing the U.S. Any doubts about the U.S. and Europe’s long term objectives to secure monopoly rights for their IP industries should be resolved by looking at the EU’s proposals in the EU-India FTA negotiations or the U.S.’s IP on steroids demands in the Trans-Pacific Partnership Agreement negotiations.
So far, India has stood firm. It has countered Pharma propaganda with facts and it has done so politely. But sometimes it’s appropriate to call a lie a lie, instead of merely trying to cure it with information. Pharma hopes if it repeats its myths and misrepresentations often enough, a gullible public will believe it. But India must stand firm and protect its high-standard patent regime. It must protect its status are the pharmacy of the developing world – millions of lives are at stake.
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