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Should we have an international forum to resolve clinical trial mishaps?

How to minimize cross-border clinical trial mishaps? Conflicts of interest abound. Isn't an international forum the obvious answer? No, for the simple reason that international guidelines have existed for more than 50 years yet they haven't prevented clinical trial mishaps.In 1963 the World Medical Association (WMA) created and endorsed the Declaration of Helsinki (DoH). Purpose of the DoH is to guide the proper ethical conduct of human clinical trials, and to prevent clinical trial mishaps.Has the DoH prevented clinical trial mishaps? Obviously not if one goes by the high profile Phase 4* HPV (Human Papilloma Virus) Vaccine trial in India, a multinational endeavor stopped in 2010 by the Government of India, leading to an Indian Parliamentary inquiry as well as an ongoing PIL (Public Interest Litigation) at the Indian Supreme Court. Let's examine these issues in sequence and see where that leads us.First, let's examine the DoH, the WMA's explicitly drafted recommendations for the proper conduct of human clinical trials.Next, let's examine examine the history of informed consent, particularly how it came into existence. This history teaches us that informed consent can either promote or prevent clinical trial mishaps. Promote mishaps when trial administrators and funders pay lip service to it (tokenism) and aren't held accountable. Prevent them when used sincerely to promote and preserve patient autonomy.Since existing structures appear inadequate to the task, is there another way to prevent or minimize clinical trial mishaps? Yes, public pressure for stricter implementation of existing country-specific laws. Where existing country-specific laws prove inadequate, the citizenry need to push their government to enact clearer and more comprehensive laws. Two compelling reasons for this. For one, citizens of one country are unlikely to be as motivated in seeing justice done for clinical trial mishaps that happen in another country. For another, isn't it morale-boosting and integral to a citizen's identity to hold their government accountable rather than have some foreign entity step in and do so on their behalf? In fact, isn't the alternative shameful? Here, the history of the use of informed consent is a poignant guide, teaching us that the central problem is not absence of adequate laws but rather lack of accountability in the existing system.* A Phase 4 trial is a post-approval surveillance trial where effects are monitored on thousands of people to uncover unforeseen side-effects.The Declaration of Helsinki (DoH)The DoH was the WMA's declaration of ethical principles for medical research involving human subjects.From 1963 till 2013 it has undergone 7 revisions.The history of the DoH is pockmarked with controversy.For example, the 5th revision in 2000 was approved without consensus from national medical associations in the aftermath of the controversial sub-Saharan nevirapine studies on vertical HIV transmission. These studies revealed a blatant double standard in human clinical trial practice. A 1994 US study (1) showed that Zidovudine (AZT) given intravenously prenatally, during delivery and postpartum reduced perinatal (vertical) HIV transmission by ~2/3rds. It then became the standard of care in developed countries. However, when it came time to test whether the 2nd generation drug nevirapine could also minimize or prevent vertical transmission in the high-risk but much poorer sub-Saharan populations, the 1st world trial sponsors chose to give a single nevirapine dose to pregnant women during labor and once to their infants within 72 hours of birth (2). This when it was already known 'at the time that single-dose nevirapine would not be as effective as more comprehensive and much more expensive treatment regimens that also targeted transmission during pregnancy (3). Rationale of the trial sponsors? The needed infrastructure, comprehensive perinatal care and drug cost couldn't be adequately provisioned at the trial site. In other words, in a tussle between money and ethics, money won.The 7th revision of the DoH, adopted in October 2013 at the 64th WMA General Assembly in Fortaleza, Brazil, also has its share of controversy. In particular, it says 'placebos, no intervention or any intervention less effective than the best proven one may be used only when the patients who receive them will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention' (4). In response, the Latin American and Caribbean Medical Confederations refused to approve this wording of placebo use stating, 'the poor and vulnerable populations, discriminated by their lack of resources, cannot be subjected to biomedical research that have levels of safety less than those applied to more developed societies' (5, 6).Another ambiguity of the 7th DoH revision is 'risk of serious or irreversible harm'. Which is it, not treating a simple skin cut or not treating an HIV positive pregnant woman? After all, don't we live with a vast, unbridgeable chasm in health care access between the haves and have-nots so much so that even a simple skin cut could be construed as 'risk of serious or irreversible harm' in the 1st world even as an HIV positive pregnant woman is left untreated in the 3rd world?What is informed consent and why is it essential in human clinical trials?Informed consent stems from the need for patient autonomy.In a clinical trial, patient autonomy is the basic human right of a trial participant to not be subjected to medical research abuse.The egregious Nazi regime medical experiments on concentration camp inmates drove the need to prevent future outright medical research abuse so in 1947 the Nuremberg Code (Nuremberg Code) was created, i.e. research ethics guidelines for human experimentation.Article 1 of the Nuremberg Code explicitly identifies the need for consent, 'The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity' (See page 182 of 7).Did the 1947 Nuremberg Code prevent ongoing and future medical abuse?Obviously not since the Tuskegee syphilis experiment ran uninterrupted in the USA from 1932 until 1972. In this study, African-Americans diagnosed with syphilis were left untreated because the physicians wanted to follow the natural disease progression. This is a painfully compelling example that an international code alone is insufficient in and of itself in preventing future or ongoing outright medical practice abuse, let alone clinical trial mishap.Something more than an international agreement is needed to prevent medical research abuse of human trial participants. History teaches that this something more is lawsuits. In particular, today's informed consent is the legacy of two key US medical malpractice lawsuits.How did informed consent come into existence in human clinical trials? The two landmark US lawsuits that helped create it.The 1st lawsuitThe judge in the first case, Salgo v. Leland Stanford, Jr. University Board of Trustees (1957), coined the phrase 'informed consent' in his jury instruction.The plaintiff Mr. Salgo's now defunct treatment entailed 'puncturing the aorta through the back in order to inject a radio-opaque dye, and was left with permanent paralysis of the legs. According to the direction given to the jury: “The physician has . . . discretion [to withhold alarming information from the patient] consistent, of course, with the full disclosure of facts necessary to an informed consent” ([1957] 317 P.2d 170 (Cal. Ct. App.) at 181)' (8).'discretion to withhold alarming information' and 'full disclosure of facts necessary to an informed consent' are obviously contradictory in nature. Regardless, this was the first instance requiring that disclosure to patients needed to conform to 'professional practice standard', i.e. what is expected from a reasonable health-care practitioner (8).The 2nd lawsuitIn the second US case, Canterbury v. Spence ([1972] 464 F.2d 772 (D.C. Cir.), the patient fell out of his hospital bed after undergoing a spinal procedure and suffered major paralysis.Since the patient had not been warned about 'the possibility of this rare outcome', the 'professional practice standard' was deemed inadequate by failing to respect the patient's self-determination.Instead it gave way to the patient-centered 'reasonable person standard', i.e. what a reasonable patient considers necessary and sufficient to know rather than what health-care practitioners consider necessary to disclose (9).According to the philosopher Peter Singer and his colleague Helga Kuhse, 'this single move served to overcome three main weaknesses of the professional practice standard: first, that agreed professional standards of disclosure were typically set too low to satisfy patient demand for information; second, that there were no agreed standards for new procedures; and, third, that patients were put at a significant disadvantage in having to rely upon expert witnesses (usually other health-care practitioners) in disputes about standards of care' (8).With a 'reasonable person standard', health-care providers have to disclose to patients or clinical trial participants the four elements necessary for informed patient consent: the nature (therapeutic/not), risks, alternatives and benefits of the procedure and/or treatment. When the patients or clinical trial participants are below the age of consent, the disclosure is given to and consent sought from the parents or legal caregivers.A recent human clinical trial mishap: Phase 4 HPV (Human Papilloma Virus) Vaccine study in IndiaTo generate data to support inclusion of HPV vaccine in India's UIP (Universal Immunization Programme).Actual vaccinations started in 2009 in the Indian states of Andhra Pradesh and Gujarat.Girls aged 10 to 14 years of age, i.e. dependents so consent presumably sought and obtained from parents/caregivers.Two-component trial: Phase 4* HPV vaccine clinical trial and observational research on vaccine delivery.Designed and executed by PATH (Program for Appropriate Technology in Health), a US-based NGO, in collaboration with the ICMR (Indian Council of Medical Research) and the State Governments of Andhra Pradesh and Gujarat.The vaccines: Merck's Gardasil and GlaxoSmithKilne's Cervarix.Funded by the Bill and Melinda Gates Foundation.Trial suspended by the Government of India in April 2010.After the reported post-vaccination deaths of 7 girls in the two states, the Indian Parliament's Standing Committee on Health investigated this study, and released its report in August, 2013 (10).Salient problems identified by the Committee (page 11 of the Committee report, see reference 10):'6.14 The Inquiry Committee, while going through the above report, noticed the following irregularities and discrepancies in the study:The warden/teachers/headmasters were not given written permission by the parents/guardians to sign on behalf of their girls.On many forms witness had not signed and of the forms which are signed, it is not clear whether they are signed by full time government employees, as per rules.Neither the photograph nor the photo ID card of parents/guardians/wardens is pasted in consent form.On many forms investigator has not signed.On some forms signature of parents/guardians is not matching with their names.The date of vaccination is much earlier than the date of signature of parents/guardian in the consent forms. Apparently they were obtained post-facto.In some forms, the name is of the father but signature is of probably mother (lady’s name).'Salient conclusions of the report (pages 14-15 of the Committee report, see reference 10):'(i) Irregularities in obtaining consent forms and actual implementation of the consent process;(ii) Lack of monitoring and preparedness to deal with serious adverse events;(iii) Inclusion of vulnerable and tribal population groups;(iv) Blurring of distinction between Universal Immunization Programme and PATH study;(v) Absence of insurance coverage for the study participants; and(vi) Inclusion of the statement in the consent form that “you will not be charged for your daughter to receive the vaccine” that could be construed as covert inducement.'News reports (11, 12, 13, 14, 15, 16, 17, 18) and sponsor comments (19, 20) about this trial.So whether or not the girls' deaths were attributable to the HPV vaccine, the resulting investigation revealed a thoroughly messed up informed consent process and seriously inadequate process for reporting adverse events. But wait a minute? Isn't all this thoroughly covered by the overarching DoH? Let's examine the relevant DoH provisions to make sure.In any case, so far the government actions have resulted in predictable shake-ups, committees, new procedures, even though existing procedures appear to be adequate on paper.What about accountability? Who is responsible? When human clinical trials are outsourced and off-shored, who bears responsibility for adverse events, especially for seemingly unanticipated adverse events, as happened in this Phase 4 Indian HPV vaccine trial? Let's examine a relevant landmark and precedent-setting judgment (18).In 2012, a judge in Argentina upheld fines against GlaxoSmithKline, the sponsor of an Argentinian clinical trial testing the safety of the vaccine Synflorix against pneumococcal disease in children.Issues of informed consent?In some instances, consent was given by parents who were minors themselves.Grandparents who were not authorized to give consent for their grandchildren.A child vaccinated even after mother explicitly refused her consent.Signatures on consent forms not matching those of the individuals giving consent.GlaxoSmithKline appealed the fine using the defense that alleged errors and poor documentation in the informed consent process were a mere formality that didn't pose actual risks to trial participants.The judge rejected this defense and upheld the fine, against both the investigators and the sponsor.His rationale? Even minor deficiencies in trial procedure could later become relevant since adverse health effects might appear only in the future.This precedent-setting judgment bestows supervisory duty on the trial sponsor regarding informed consent. It also paves the way for hope. For example, the Indian Supreme Court is well-known to be highly responsive to PILs, using them as tools to demand improvements in state laws and regulations (Public interest litigation in India). Currently, it's considering one such PIL with respect to the Phase 4 HPV trial (18). In India, PILs arise when the State is perceived to have violated constitutional and/or statutory provisions, and they have served as indispensable bulwark protecting essential rights of Indian citizens.Further, since this case involved US and UK trial sponsors and manufacturing companies, this PIL includes an amicus brief (21) submitted by the European Center for Constitutional and Human Rights 'outlining the legal framework on clinical trials in the respective home countries' (18), in order to cover obvious gaps in judicial precedents.Finally, and more importantly, in our globalized age of cross-border, outsourced and off-shored clinical trials, an obvious and perhaps steep learning curve lies ahead for all entities involved in them, namely, government regulatory bodies, sponsors, investigators and other health-care staff. Especially these latter need to be rigorously trained in the ethical and legal aspects of human clinical trials. It then becomes a natural and necessary mandate for each and every national medical association and department of health to help ensure that such training becomes part and parcel of each country's health care practice (22), i.e. that it no longer remains the select purview of developed countries' health care infrastructure. Now, wouldn't that be leveling of a playing field that actually matters, one of autonomous life and death?BibliographyConnor, Edward M., et al. "Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment." New England Journal of Medicine 331.18 (1994): 1173-1180.Marseille, Elliot, et al. "Cost effectiveness of single-dose nevirapine regimen for mothers and babies to decrease vertical HIV-1 transmission in sub-Saharan Africa." The Lancet 354.9181 (1999): 803-809.Millum, Joseph, David Wendler, and Ezekiel J. Emanuel. "The 50th anniversary of the Declaration of Helsinki: progress but many remaining challenges." Jama 310.20 (2013): 2143-2144 Page on nih.govWorld Medical Association (WMA). Declaration of Helsinki. Amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013. WMA Archives, Ferney-Voltaire, France. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human SubjectsConfederacion Medica Latinoamericana y el Caribe (CONFEMEL). Declaracion de Pachuca Sobre la Revision de Helsinki. 22 and 23 November 2013. (Accessed May 5, 2014. Page on confemel.comHellmann, Fernando, et al. "50th Anniversary of the Declaration of Helsinki: The Double Standard Was Introduced." Archives of medical research 45.7 (2014): 600-601.http://www.loc.gov/rr/frd/Military_Law/pdf/NT_war-criminals_Vol-II.pdfA Companion to Bioethics, Second Edition. Helga Kuhse, Peter Singer, editors. A Companion to Bioethics; A Companion to Bioethics, Second EditionFaden, Ruth R., Tom L. Beauchamp, and Nancy M. King. "A history and theory of informed consent." (1986).Page on 100.47.5Mudur, Ganapati. "Human papillomavirus vaccine project stirs controversy in India." BMJ 340 (2010).Mudur, Ganapati. "Row erupts over study of HPV vaccine in 23 000 girls in India." BMJ 345 (2012).Sharma, Dinesh C. "Rights violation found in HPV vaccine studies in India." The Lancet Oncology 14.11 (2013): e443. Page on thelancet.comSuba, Eric J., and Stephen S. Raab. "Cervical cancer mortality in India." The Lancet 383.9931 (2014): 1804. Page on thelancet.comCalls in India for legal action against US charityClinical trials in India: ethical concernsIndia Outlines Plans for Upgrading Clinical Trial ProceduresTerwindt, Carolijn. "Health Rights Litigation Pushes for Accountability in Clinical Trials in India." Health and human rights 16 (2014): 2. Health Rights Litigation Pushes for Accountability in Clinical Trials in IndiaLaMontagne, D. Scott, and Jacqueline D. Sherris. "Addressing questions about the HPV vaccine project in India." The Lancet Oncology 14.12 (2013): e492. Page on thelancet.comStatement from PATH: cervical cancer demonstration project in IndiaAmicus curiae brief concerning non-state actor responsibility in clinical trials, November 22, 2013, submitted to the Supreme Court of India by the European Center for Constitutional and Human Rights and the Essex Business and Human Rights Project in Writ Petition (Civil) No. 558 of 2012, on file with ECCHR.Poongothai, Subramani, et al. "Why are clinical trials necessary in India?." Perspectives in clinical research 5.2 (2014): 55. Why are clinical trials necessary in India?Thanks for the A2A, Kritika Gupta.

How can DNA data be misused?

People who pay to have their DNA sequenced give up any right to determine or control what is done with that information. The "privacy" statements use paragraphs of legalese to disguise the fact that there is actually almost no protection for the clients' most intimate, personal information.Most people have heard the term ‘DNA’ and seen the ‘double helix’ diagrams. Many are also aware of the growing use of DNA by the ‘authorities’ across the world. Governments in the West and India in particular are engaged in creating various biometric databases for the claimed purposes of ‘identity proof’ and ‘law enforcement’. But how many people realise how dangerous such a database is, or the potential for its misuse?There also appears to be an unwavering belief that DNA is an infallible tool for use as evidence in legal cases.With these ideas in mind I thought I would conduct some research into the background of DNA, the fallibility of its use, and the dangers of such a database and its accessibility by the state.Wikipedia summarizes:“Deoxyribonucleic acid (DNA) is a molecule that encodes the genetic instructions used in the development and functioning of all known living organisms and many viruses. Along with RNA and proteins, DNA is one of the three major macromolecules essential for all known forms of life. Genetic information is encoded as a sequence of nucleotides (guanine, adenine, thymine, and cytosine) recorded using the letters G, A, T, and C. Most DNA molecules are double-stranded helices, consisting of two long polymers of simple units called nucleotides, molecules with backbones made of alternating sugars (deoxyribose) and phosphate groups (related to phosphoric acid), with the nucleobases (G, A, T, C) attached to the sugars. DNA is well-suited for biological information storage, since the DNA backbone is resistant to cleavage and the double-stranded structure provides the molecule with a built-in duplicate of the encoded information.”And under the sub-section heading ‘Forensics‘:“Forensic scientists can use DNA in blood, semen, skin, saliva or hair found at a crime scene to identify a matching DNA of an individual, such as a perpetrator. This process is formally termed DNA profiling, but may also be called “genetic fingerprinting“. In DNA profiling, the lengths of variable sections of repetitive DNA, such as short tandem repeats and minisatellites, are compared between people. This method is usually an extremely reliable technique for identifying a matching DNA.However, identification can be complicated if the scene is contaminated with DNA from several people.DNA profiling was developed in 1984 by British geneticist Sir Alec Jeffreys,and first used in forensic science to convict Colin Pitchfork in the 1988 Enderby murders case.“In more basic terms, a DNA sequence makes up a gene, and each gene or combinations thereof supposedly determines a particular characteristic in an organism, such as that of eye colour or natural strength. In turn, a series of genes make up a chromosome. In essence DNA appears to be an individual’s unique biological code.A human DNA sample may potentially hold the full genetic blueprints (or ‘genome‘) to create, or recreate that human, and because that code is unique, a sample can be used as a ‘genetic fingerprint’ to trace the source human.Around ninety-five percent of DNA is still not understood. Anything outside of the known percentile is technically referred to as ‘noncoding DNA‘, or more often by the arrogant label ‘junk DNA‘, equating a lack of understanding with a lack of purpose. Surely nature doesn’t make mistakes?There are also regular announcements involving discoveries relating to the purpose of previously misunderstood genes, such as the 2012 announcement of the discovery of the first gene believed to be linked with intelligence. In the wake of the Sandy Hook incident scientists are apparently searching samples from the alleged gunman Adam Lanza in an attempt to find a gene for ‘evil’ – though this headline is somewhat superficial.Perhaps the most well known use of DNA is in the confirmation of paternity. Indeed it is a deep vein mined by exploitative daytime T.V. talk shows, such as the one hosted by Jeremy Kyle in the UK. Kyle’s format includes presenting members of the underclass, often ‘teen mothers’ with multiple sexual partners, with the results of DNA tests which verify the identity of the child’s father.Because the genome holds the entire hereditary code, it can also highlight potential hereditary health problems someone might experience, such as a predisposition to heart disease or a specific type of cancer. One of the more controversial aspects of modern genetics is that the human race now has the ability to alter the genetic code of a developing foetus, and alter potentially ‘faulty’ genes with ‘healthy’ genes from a third party, in effect creating a child with three parents, something that can also happen through modern IVF techniques. Britain has recently become the first nation to officially approve ‘germ-line gene therapy’ to allow for the switching in or out of various genes in human embryos. This poses serious moral questions. A prospective parent who would choose to alter a potentially ‘faulty’ gene in the code of their unborn child would also be removing some of their own genetic lineage arguably making the child less their own?And further than hereditary diseases, infectious diseases (i.e. diseases caught as an adult) such as HIV also show up in DNA. In fact DNA based tests are now becoming the norm in looking for these types of diseases.Just how far this science has progressed and how accessible it has become has been demonstrated by New York artist Heather Dewey-Hagborg in her ‘Stranger Visions‘ project. The artist realised she could harvest the DNA from discarded chewing gum and cigarette butts then recreate the faces of the strangers who had used the items.While there are undoubtedly limitations to her technique, for example she cannot define the age of the human source from a sample – yet, the ramifications of this are troubling when one remembers that this level of ability is available to a private individual, without the resources of an NGO, corporation, or a government agency. The ability of those kind of heavily funded entities to manipulate available DNA must be far more advanced than Dewey-Hagborg’s.DNA is also the foundation of the cloning process, where genes can be removed from their original chromosome and placed in an artificially constructed carrier cell which then allows the genes to replicate independently of their natural source lifeform (be that human, plant, animal, or bacteria).The first publicly announced cloned mammal was ‘Dolly the sheep’, ‘born’ July 5th 1996 in Scotland. Dolly was put down while suffering from a lung illness in 2003, not even seven years old – the average sheep lifespan around ten to twelve years. It was also disclosed that Dolly had been suffering from arthritis during the final year of her life. Both of these ailments are common to older sheep, and it transpired that the source sheep, from which Dolly had been cloned, was already six years old when the cells used in the cloning process were harvested.Further controversy was ignited after it was discovered that meat from the offspring of cloned cattle had appeared in the food chain of the UK, followed by the appearance of actual cloned meat in both the UK and the U.S.Had Dolly continued to age from the point at which the cells were harvested, rather than from the point of a newborn lamb? Would this have any effect on consumers eating similarly cloned meat? This is something that was, and still is, unclear.After the announcement of the creation of Dolly, discussions have taken place worldwide on a human cloning ban. In the U.S. Congressman Andy Harris (Republican, Maryland) has recently introduced a bill (H.R. 2164) to ban somatic cell nuclear transfer (SCNT), the technical name for the cloning process. But even if such a ban were to be effected, having seen the lack of respect government and its entities have already shown for their own laws, whether that be in the financial arena through the LIBOR scandal amongst others, to the recent Prism scandal involving the recording and tracking of the communications of literally everyone, what’s to say that any government would obey or enforce such a ban regardless of the legal status?DNA clearly has many powerful applications, and some positive uses, particularly in the detection, and possible treatment of disease. DNA use has the potential to spot or prevent diseases early on and if a sample truly contains the entire blueprint for someone’s body, perhaps we are simply waiting for the announcement of discoveries allowing for the repair of faulty eyes or ear drums, or even the re-growing through cloning of missing limbs, etc.Now that we have some idea of what DNA really is and how it can be used let’s explore the potential downside and ability for misuse.Following the second world war the ‘Berlin wall’ was erected and Germany was split into two. The East German side (officially titled the ‘German Democratic Republic‘ or ‘GDR’) became a repressive authoritarian state ruled by the Soviets, until the country collapsed in 1989. The repression was carried out by the utterly ruthless state security apparatus known as the ‘Stasi‘. At it’s height in the 1980s, the membership of the Stasi including it’s informers, supposedly ammounted to a fifth of the GDR population!In the 1970s the Stasi began implementing a new operating technique called ‘criminal odorology’ [chapter 12 page 303]. This process involved interviewing an arrested subject, and at the point at which they began to sweat a Stasi member would enter the room holding a cloth with tweezers. The cloth would then be used to swab the subject’s sweat. Alternatively the subject may have been seated in a customised chair containing the cloth (as depicted in the 2006 German movie ‘The Lives Of Others‘ at approximately [0h05m]). The cloth was then placed into a vacuum sealed jar known as a ‘smell conserve‘, whereupon the subject was informed they had recorded his ‘scent’.The Stasi’s use of criminal odorology was often cited as one of their most disturbing and intrusive activities, in fact it has even been described as ‘perverse’ – yet it is nowhere near as intrusive (or disturbing) as placing someone’s DNA on a record somewhere.In law, there is a basic presumption that the burden of proof lies with the accuser. This is most famously expressed in the maxim ‘innocent until proven guilty‘, and dates back at least as far as the Romans. This is one of the most basic principles our entire society is based on. It is a rule that stops people constantly looking over their shoulders in a state of paranoia that they may be accused of something and have to prove their innocence. If one is accused but was home alone, one cannot provide any witnesses to verify one’s innocence. On the other hand, if one committed the crime surely there must be some evidence to corroborate this?The very existence of a DNA database is a fundamental reversal of this. By holding evidence in the form of our DNA, we are being declared ‘guilty until proven innocent’ which we will ultimately have to do by dying without ever having been convicted of a crime. It’s tantamount to dunking an accused witch, while the only way to prove her innocence is to drown.Though some may tediously argue “if you’ve got nothing hide, what’s the problem?” – would those people stick to that belief if the police suddenly barged in to their home and demanded fingerprints?It comes as no surprise that the UK is a leader in genetic surveillance with an estimated six million entrants on the DNA database (roughly ten percent of the population). The UK is also the leader in CCTV monitoring, and until the recent Snowden affair, was poised to be the leader in communication surveillance as well.Since 2004 the police have been granted the power to unlawfully take the DNA of a subject arrested for any ‘recordable offence’ without consent and regardless of whether charges are pressed, yet the police still continue attempting to expand upon these powers. In the U.S. a recent Supreme Court decision has granted similar powers, allowing for the swabbing of people arrested but not charged.There are also many examples of flaws in collection methods by investigators, bad handling in laboratories, or collection during an overlong time duration, all of which have the potential to contaminate samples. This was perhaps most famously highlighted in the Meredith Kercher murder investigation in Italy. Add to that findings by Israeli scientists that DNA evidence was ‘easy to fake‘, and comments by Tania Simoncelli of the American Civil Liberties Union (ACLU) who stated “DNA is a lot easier to plant at a crime scene than fingerprints” and this supposedly infallible technique starts to look problematic.If DNA can be used in cloning then surely this allows for the possibility of cloning (and planting) genetic evidence?A DNA database held by a well funded entity such as a government has the power to discover what diseases individuals may be prone to, what diseases they have contracted, their parentage, and potentially even the ability to clone them (or at the very least experiment with cloning humans).This information offers the holder unprecedented power over individuals. A rape victim wishes to withhold the identity of the child’s father? The state knows. Contracted HIV through sexual contact? The state knows. How about the possibility the state may decide to profit by selling your personal information to private companies?If that last thought doesn’t get your immediate attention consider this. An insurance company purchases access to your data and discovers a hereditary predisposition to some potentially fatal illness. As a result your life insurance premiums double overnight…..The movie ‘Gattaca‘ (1997) dealt with an extension of this concept. A dystopic future where pilots are refused jobs on the basis of hereditary predisposition toward certain diseases regardless of whether the ‘diseased’ genes remained dormant.But DNA must hold even more potential than we have already been made aware of, otherwise why would the U.S. secret service feel the need to ‘protect’ the DNA of the President as stated by Ronald Kessler’s 2009 book entitled ‘In The President’s Secret Service‘?If DNA offers a unique code to every individual, is it not possible to create toxins or diseases that only target a specific genetic structure? A poison could be fed to everyone at a banquet, but would only affect one victim with the targeted genes…..This is not so outlandish a claim. Prior to his death and during the same period as other South American leaders were involved in cancer scares, Venezuelan leader Hugo Chavez said:“It’s very difficult to explain, even with the law of probabilities, what has been happening to some of us in Latin America. Would it be so strange that they’ve invented technology to spread cancer and we won’t know about it for 50 years?”In September 2000, the ‘neoconservative’ think tank the Project for the New American Century (PNAC) released the document ‘Rebuilding America’s Defences‘. This document has become infamous both for promoting a doctrine of pre-emptive warfare to take control of global resources, and for including this sentence concerned with galvanizing support for the doctrine one year prior to 9/11:“Further, the process of transformation, even if it brings revolutionary change, is likely to be a long one, absent some catastrophic and catalyzing event––like a new Pearl Harbor.”But the document also contains this lesser publicised sentence from page 66:“And advanced forms of biological warfare that can ‘target’ specific genotypes may transform biological warfare from the realm of terror to a politically useful tool.”A call to develop race specific bio-weapons that would only attack certain gene sequences, possibly specific family bloodlines or ethnic groups is perhaps the most chilling of all the suggestions contained within the document. The very definition of ‘genocide‘. And where would the source DNA code for such biological weapon experiments come from? The DNA database?While these weapons might kill, they might not necessarily have to. As scientists identify the purpose of each individual gene in the genome, and with their growing ability to switch ‘faulty’ genes with ‘approved’ ones, it may be possible to switch out a chosen gene, such as that for aggression, with a replacement, say a ‘compliance’ gene. Perhaps this could be delivered through the water supply in a similar manner to fluoride now, or through an airborne nanotech smartdust?These are obviously only theoretical suggestions but it’s telling that PNAC felt it important enough to note.It seems after only seven decades, roughly a single lifetime, humanity has forgotten the horrors of the Nazi’s eugenics programme. This programme designated certain subsections within society as a ‘genetically contaminated’ burden on the remainder. These subsections comprised of the physically or mentally disabled, the ‘racially impure’, and the ‘criminally minded’ which included dissidents. The ‘solution’ to tackling these genetic inferiors ‘bringing down the racial quality of the nation’ began with sterilization and eventually progressed into an involuntary ‘euthanasia’ programme.The Nazi’s also brought in a standard identity card for the population. Jews and Christians may not have a distinctly different physical appearance as for example black and white people. The card of a Jew would feature a letter ‘J’ stamped on the front and this allowed German ‘officials’ to single out Jews with great ease on presentation of the card, perhaps for arrest, while non-Jews could be given superior treatment.Eugenics was not confined to Nazi Germany either, having originated in the UK with Sir Francis Galton, and partly inspired by Galton’s cousin Charles Darwin with his theories of ‘natural selection’. It’s ironic that if Darwin’s natural selection theory is true then surely ‘genetically contaminated bloodlines’ would naturally work their way out of the human race dispensing with the need for eugenics! The famous British concept of selective ‘breeding’ is also rooted in these same ideas.In the U.S. the Rockefeller Institute bankrolled the Nazi’s leading research centre, the ‘Kaiser Wilhelm Institute of Anthropology, Human Heredity, and Eugenics‘ and assisted in domestic programmes too, as did both the Carnegie Foundation and the Harriman railroad fortune, amongst others. Some U.S. domestic programmes continued as late as the 1970s!Alternatively, genetic weapons could be used as part of the ‘depopulation agenda’. It appears that many of the ‘farmers’ of society think ‘the herd’ has grown too large. Ted Turner, the founder of CNN who also happens to be the largest landowner in the U.S., discussed depopulation in an interview with Charlie Rose.Microsoft’s Bill Gates, whose father sat on the board of ‘Planned Parenthood’ (originally a racist Eugenics group) has also been promoting depopulation. In a 2010 ‘TED talk’ [the specific excerpts referred to are here] Gates discussed reducing CO2 emissions by bringing down the population of the world using vaccines. It has been suggested that this was not a slip of the tongue or faux pas, but rather Gates’ logic is that when the survival rate of children in the developing world rises, families are likely to have fewer children. Even if this claim were true I suspect it would take decades to create the huge population decline Gates wants to see. Later in the talk he discusses his one ‘wish’ for the future, the creation and implementation of zero emission energy technology, which he ends by saying:“If you give me only one wish in the next fifty years…..” “…If we don’t get this wish, the division between the people who think short term and long term will be terrible, between the U.S. and China, between poor countries and rich, and most of all the lives of those two billion will be far worse…..”‘Two billion’? In ‘fifty years’? Where did those numbers come from? Is that the population number the depopulists are aiming for? Ted Turner also seems to think two billion would be the perfect number of occupants for the planet.So how do these people intend to reduce population to that number within fifty years? Current White House science ‘tsar’ John P Holdren wrote in his 1977 book ‘Ecoscience: Population, Resources, Enviroment‘ (cowritten by Paul and Anne Ehrlich) on page 787-788:“Adding a sterilant to drinking water or staple foods is a suggestion that seems to horrify people more than most proposals for involuntary fertility control. Indeed this would pose some very difficult political, legal, and social questions, to say nothing of the technical problems.”What if someone created a bioweapon that could switch off the gene for ‘fertility’? In 2001 the U.S. company Epicyte created a genetically modified ‘spermicidal corn‘ so the world clearly cannot be far away from that eventuality, if not already there. Would these depopulists use such a weapon? Whether targeted at a specific ethnicity or the human race as a whole (assuming ‘insiders’ have some kind of vaccination) this would be sheer insanity.What unforeseen effects could arise from the use of genetic weapons? Rootworms have already adapted to genetically modified ‘bt-corn’ which produces it’s own insecticide and modified corn stalks are so tough farmers have found a need to fortify tires of farm machinery such as tractors with kevlar as the stalks damage the tires! While these two problems may not have the gravity of anti-human genetic weapons they do demonstrate the law of unforeseen consequences. ‘Children Of Men‘ (2006) hints at just such a scenario. A not too distant future civilisation is all but collapsing after an unexplained lack of human pregnancies for almost two decades. While the cause is never explored, it can certainly be read as a side effect of a genetic weapon unleashed by depopulation supporters.The UK, the U.S. and India, amongst other countries, have been spearheading the creation of biometric databases with the intent of holding the genetic information of their entire respective populations. The UK attempted to introduce biometric ID cards in 2005. This attempt failed though it has often been claimed that this was down to the costs for individual citizens. They have, however, gotten around this to some degree by introducing a biometric requirement in the application for a passport. At this point the requirement is only for facial biometrics taken from a specific type of photograph rather than genetic details. EU signatory countries to the Schengen agreement have the additional non-genetic biometric requirement of fingerprint data.One reason cited for the use of biometric ID cards during the 2005 campaign to promote them, was the threat of terrorism and the possible prevention of a new 9/11. Even the mainstream media pointed out that the alleged nineteen hijackers were foreigners to the U.S., and so that even if the U.S. had been implementing an ID card system, it would have been useless in stopping these attackers, who got in to the country through an old cold war CIA consulate in Saudi Arabia that fast-tracked Visas to the Soviet fighting Mujahideen.Home secretary Charles Clarke famously commented “I argue the ID card system is a bulwark against the surveillance society, the Big Brother society“, probably the greatest real world example of Orwellian ‘double-think’ ever. A little over a week later the July 7th bombings occurred, allegedly perpetrated by four British born Muslims (though never proven in a court of law), and offering a convenient justification for ID cards.By October of the following year Tony Blair was calling for the inclusion of everyone; “The number on the database should be the maximum number you can get.”Similarly, India’s 15th census in 2010 attempted to create a non-genetic biometric database and I.D. card scheme for the entire 1.2 billion population. Though the ID aspect remains incomplete with a massive 200 million people registered, animosity toward the database is growing, partly caused by a lack of legal protections on the collected data, partly through the centralisation of all that information, and partly because both fingerprint and retinal scans have been shown to be ‘spoofable’.Regardless of country, these non-genetic I.D. requirements are an obvious example of incrementalism toward full DNA collection. First the collection of facial biometrics, then later the collection of fingerprints, then later still iris scans, and finally DNA itself. Once people accept one biometric, the misleaders have a short pause before attempting to implement the next, and so on.In 2009 The Telegraph published an article following a timeline of selected events surrounding the DNA database. Some excerpts:*May 5, 1998: Chief Supt Peter Gammon, president of the Police Superintendents’ Association, calls for the establishment of a national DNA database for the entire population.*September 16, 1998: Det Ch Supt Robert Taylor, of the elite National Crime Squad, says a DNA sample should be taken from every baby at birth to help solve crime.*February 18, 2001: Professor Sir Alec Jeffreys, the scientist who discovered genetic fingerprinting, calls for the entire population to be DNA tested in a bid to combat serious crime.*September 5, 2007: Lord Justice Sedley proposes creating a DNA database of everyone in the UK, provoking outrage from civil libertarians.We see a pattern emerging of repeated calls to profile everyone, criminal and innocent alike. There is also this:*March 4, 2008: Metropolitan Police Commissioner Sir Ian Blair, Britain’s most senior policeman, raises the prospect of a EU-wide DNA database to catch criminals.In the wake of Edward Snowden’s recent revelations and the Prism scandal providing further confirmation that certain countries are swapping intelligence with each other, is it not likely that these same countries are also swapping DNA database information? If and when the U.S. introduces DNA swabbing for all foreign visitors, and the UK does the same, will the U.S. send back copies of the DNA data of British citizens to the UK, and vice versa?When it comes to biometric or genetic ID, why would we require it? We’ve never needed it before and the world still functioned. On the other hand, a modern day digital identity card or passport containing either coded genetic data or allowing for a cross reference against a database containing the same data could allow for the singling out of less distinct minorities as with the Jews of Nazi Germany.In China, it has been claimed practitioners of the spiritual exercise ‘Falun Gong‘ are persecuted by the government to the point of murder and organ harvesting. If this is true, a DNA database would simplify the targeting of victims per bloodtype for the state.The government/s controlling the DNA database have the power to know the lineage, diseases, physical characteristics, and potentially even mental characteristics or predispositions of the individual. That data could be used to plant fake evidence, which in my mind negates any real usage in criminal evidence without corroborating evidence, or it could be sold to private companies for commercial use.The database could (and most likely already does) provide source DNA for scientific research. The genetic code of database participants may already have been used in human cloning experiments. Worse still, some of this genetic material may be used to create human/animal hybrid experiments. While some of these experiments seem to offer genuine hope for medical advances in the future, other experiments appear to be attempts to find out if these things can be done, with no regard as to whether they should be done! Regardless of whether this science is for positive reasons or not, if samples from the database are being used, there is the question of consent.It would be naive to think the threat of targeted assassination or genocide through DNA specific bioweapons is likely to go away in the event of a DNA database shut down either. After all the human body sheds around a third to half a billion skin cells a day! If ‘they’ want your genetics it’s very difficult to stop the acquisition of them. Plus government doubtless already has a large range of samples across all ethnic groups. But this does not mean we shouldn’t still fight against the existence of the database to begin with.These DNA and biometric IDs and passports should receive large scale boycotts. The irony, of course, is that if a DNA based passport is introduced, the people who do not wish to hand over their genetic code will be the ones who can’t leave!Personally, I am not opposed to the use of DNA testing within murder investigations or sex crimes, though with additional corroborating evidence such as witness testimony, and the proviso that innocent parties have their samples destroyed under threat of imprisonment for the failure to do so. But I am in complete opposition to the carte blanche collection and/or exchange of private individuals’ information including DNA data between governments or between governments and private agencies.‘Power corrupts…..’

Comments from Our Customers

I wish the overall ease of use was there. When I run OCR it will usually scramble the text and I have to find a way to remove whacky symbols and dark discolorations. I used the trial 7 software and it worked much better than the version 6 I bought, but this patch should be made available for version 6 users instead of having to pay to upgrade.

Justin Miller