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Why is informed consent important in clinical trials?

Clinical trials as we understand them today are a fairly recent invention, starting with the 1947 UK Medical Research Council's study of streptomycin for tuberculosis treatment, the 1st randomized clinical trial (1).Informed consent is of even more recent vintage. Dwelling at the intersection of law and medicine, birthed by the former, imposed on the latter, informed consent and clinical medicine have had an uneasy relationship from the beginning. While landmark cases started shaping its legal doctrine already in the 19th and early 20th century, informed consent's post-WWII legal lineage in the US is easy to track, with milestone rulings starting in the 1950s through to the 1970s (2, 3, 4),The 1957 Salgo v. Leland Stanford Jr. University Board of Trustees (2) established the precedent of patient self-determination with the judge coining the phrase, informed consent, in his jury instruction, the 1st known instance of its explicit use.The 1960 Natanson v. Kline (3) established the negligence standard, as in the physician having an inherent duty to make a reasonable disclosure of risks and hazards of treatment or face possible malpractice liability.The 1972 Canterbury v. Spence (4) established the reasonable person standard, i.e., the need to disclose what any reasonable person would consider necessary and sufficient to know.According to Ruth R. Faden, Tom L. Beauchamp and Nancy M.P. King, who published the definitive text-book on it in 1986 (5), how informed consent was planted in clinical medicine, how it grew, in other words its clinical medicine lineage, that's largely lost to time. This is perhaps an unavoidable difference because medicine already walks an uneasy tightrope between patient autonomy and welfare. Absence of early peer-reviewed medical studies only emphasizes the initial reluctance with which clinical medicine incorporated informed consent, and is also emblematic of the unease with which the two co-exist. Part of the reason for this unease is the perennial existence of grey areas.Why perennially grey areas? Because the young, the elderly, the frail, the poor, the poorly educated, the intellectually impaired, and the seriously ill are a part of us, a part of us that's much more dependent and thus much more vulnerable to manipulation. As Robert Q. Marston, the then-Director of the US NIH noted in an influential speech on the subject of informed consent, 'Whether or not consent is in fact informed is admittedly difficult to assess. We often are in an uncertain situation in which inadequate information, communication problems, and the inability of the subject to comprehend-or to read-or to listen-can be misleading' (6).Pre-informed consent Clinical Medicine helps understand why it's Important, nay Critical, in Clinical TrialsAs recently as 1964-1966, a study in the US found that >50% of physicians, 53% to be exact, thought it was 'ethically appropriate for a physician not to tell a cancer patient that she had been enrolled in a double blind clinical trial of an experimental anticancer drug and was currently receiving a placebo' (5, page 89).Two of the most prominent egregious abuses in human medical research, namely, Nazi human experimentation during the Holocaust and the Tuskegee Syphilis Study* certainly cast a long shadow, necessitating clear, formal, legally binding guidelines for human experimentation. While case law verdicts helped shape the legal framework for informed consent, the cultural framework, at least in the US, arose from several other cases that drove public debate, illuminated gaps in physician understanding of informed consent, and highlighted the roles and responsibilities of research committees and funders. Careful examination of the details and circumstances of some of these prominent cases helps drive home why informed consent is not only important but indeed critical. Two of several prominent US examples that were crucial in fleshing out informed consent as it exists today are elaborated here.The Jewish Chronic Disease Hospital CaseConducted at the Jewish Chronic Disease Hospital (JCDH) in Brooklyn, New York, and funded by Sloan-Kettering Institute for Cancer Research, the American Public Health Service and the American Cancer Society. With 10 years of research on anti-cancer immune responses under his belt, in July 1963, chief investigator Dr. Chester M. Southam convinced the hospital medical director Emmanuel E. Mandel to permit injection of a suspension of foreign, live cancer cells into 22 JCDH patients.The research question? Do cancer patients reject cancer transplants or not? Obviously comparison with response of cancer-free patients, the controls, was also required.The informed consent aspect? Some were informed orally they were involved in an experiment, but not that they would be injected with live cancer cells. No written informed consent.The final insult to injury, some patients were incompetent to give informed consent.The non-cancer patients, i.e., the controls, weren't informed either that they were getting injected with live cancer cells.The grounds? Might unnecessarily agitate the participants.The defense? That it was customary in medical research that consent 'not be documented even in far more dangerous research' (5, page 161), something that sounds utterly indefensible in the year 2015.As the New York Post reported in 2013, three young physicians, Drs. Avir Kagan, David Leichter and Perry Fersko, courageously went against the prevailing status quo and refused to participate in this study (7). They also brought it to the attention of attorney William Hyman, one of JCDH's Board of Directors, who filed a suit to access hospital records to learn more about the study (8). Hyman's concerns ranged from potential patient abuse, potential reputation damage to the hospital and its possible liability. The Hyman-driven review revealed (5, page 162),The study wasn't presented to the hospital's' research committee.Physicians directly responsible for patient care of subjects involved in the research weren't consulted about the cancer cell injections.Three physicians who had been consulted by Dr. Mandel were against the research arguing 'subjects were incapable of giving appropriate consent'.In 1966, the Board of Regents of the State University of New York censured Drs. Southam and Mandel, finding them guilty of deceit, fraud and unprofessional conduct, writing in its judgment (5, page 162, 9, see Regent' decision from 10 below),'A physician has no right to withhold from a prospective volunteer any fact which he knows may influence the decision. It is the volunteer's decision to make. . . . There is evidenced in the record in this proceeding an attitude on the part of some physicians . . . that the patient's consent is an empty formality. Deliberate nondisclosure of the material fact is no different from deliberate misrepresentation of such a fact. . . . The alleged oral consents that they obtained after deliberately withholding this information were not informed consents and were, for this reason, fraudulently obtained'.The Willowbrook State School CaseAn institution on Staten Island, New York, it was then classified in a manner unthinkable today, a mere 60 years later, namely, as a place for 'defective children'. Originally designed to house 3000, by 1963 it housed >6000. With the children's severe developmental impairments amplified by poor oversight, large numbers weren't even properly toilet trained. Unsurprisingly, such conditions not just predisposed to but also facilitated easy spread of fecal-borne infections. For example, in 1954, many children contracted hepatitis (presumably hepatitis A) within 6 to 12 months of living at Willowbrook.In 1956, Saul Krugman and colleagues started a series of experiments to develop an effective prophylactic. Funded by the US Armed Forces Epidemiological Board, the US Army Medical Research and Development Command, the Health Research Council of the City of New York, and several committees at New York University School of Medicine, including its Committee on Human Experimentation, they deliberately infected newly admitted patients with isolated hepatitis virus strains. Of the 10,000 children admitted to Willowbrook after 1956, ~ 750 to 800 were sent to Krugman's special hepatitis unit. Wards of the state never included in the studies, the children's parents had given written consent. At first, parents were informed by either letter or personal interview. Later, informed consent entailed groups discussions with parents of prospective parents.From the beginning, these studies were on the radar of Henry K. Beecher. With a decidedly murky ethical background himself, nevertheless, by the 1960s he'd emerged a pioneer of informed consent with his publication in 1959 of 'Experimentation in Man'. Beecher first listed the Willowbrook study in 1966 as one of 22 'ethically dubious' experiments. His repeat highlighting of this study in his 1970 book, Research and the Individual, brought the matter to the public's attention. Criticism gained momentum with the theologian Paul Ramsey joining in and with Stephen Goldby publishing a sharply critical letter in the Lancet in April 1971 (11), with the full support of the Lancet editors who publicly apologized for having previously overlooked the issue of informed consent.Such public scrutiny forced the researchers to defend themselves in the public arena. Their defense? Since most of the children recruited in the study would contract hepatitis anyway, they weren't placed in greater danger compared to the other institutionalized children. Optimal isolation, better attention, administered the best available anti-hepatitis therapy then available, the researchers asserted that their attempt to give the selected children sub-clinical hepatitis infections would immunize them against specific hepatitis viruses (12). That's not all. Influential editors of several prestigious medical journals, namely JAMA, NEJM, Journal of Infectious Diseases, agreed with this defense, arguing such research was valuable for understanding hepatitis, had potential value to such institutionalized children, had sufficient consent provisions, didn't expose the children to unnecessary risks and was performed by competent investigators (13).The rebuttal? The studyIncreased the children's later life risk for chronic liver disease.Unlike other Willowbrook residents, study children didn't receive protective doses of gamma globulin (14).Both process and legitimacy of consent obtained for the study were also easy to challenge. Consent forms used suggested the children would receive a vaccine against the virus, some parents were only contacted by letter. A key change happened in late 1964. Willowbrook became so overcrowded that new patient admissions ceased while Krugman's special research unit continued accepting children whose parents 'volunteered' them for the study, suggesting implicit coercion into the study as a means for parents getting their children admitted to Willowbrook (15). Study reviewers and we ourselves could easily conclude that social pressures under which such parents gave their consent, especially post-1964, undermined their ability to act in the best interests of their children.As Faden, Beauchamp and King note in their book (5, page 164), while Krugman's research unit was eventually closed, debate about the ethics of the Willowbrook study never resolved satisfactorily (16) and we see remarkable parallels regarding the ethics of informed consent issues here and in the 2009 PATH-ICMR HPV (Human Papilloma Virus) clinical trial**, ***. In both, the subjects of research were minors and parents/guardians offered informed consent on their behalf, one of the perennial grey areas I referenced earlier.The Road to Today's Informed Consent Becomes ClearerWith such recent examples of egregious medical research abuses as the backdrop, in 1973, Robert Q. Marston, the then-Director of the US NIH made an influential speech (6) that highlighted the central role of informed consent in clinical trials, 'That the committee determine that the rights and welfare of the subjects involved are adequately protected, that the risks of an individual are outweighed by the potential benefits to him or by the importance of the knowledge to be gained, and that informed consent is to be obtained by methods that are adequate and appropriate', and that 'if, in a specific case, I were forced to choose between the individual and the general welfare of society, I would choose to protect the individual'.He emphasized (6) that review committees that oversee human experimentation needed to strictly adhere to three basic criteria, namely,' Protection of the rights and welfare of the subjects.Weighing of risks against benefits.Determination that informed consent is to be obtained by methods that are adequate and appropriate.'In the US, it was in 1981 that the Judicial Council of the American Medical Association (AMA) first took an explicit stance on Informed Consent (5, page 96),'INFORMED CONSENT.The patient's right of self-decision can be effectively exercised only if the patient possesses enough information to enable an intelligent choice. The patient should make his own determination on treatment. Informed consent is a basic social policy for which exceptions are permitted (1) where the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent; or (2) when risk-disclosure poses such a serious psychological threat of detriment to the patient as to be medically contraindicated. Social policy does not accept the paternalistic view that the physician may remain silent because divulgence might prompt the patient to forego needed therapy. Rational, informed patients should not be expected to act uniformly, even under similar circumstances, in agreeing to or refusing treatment'.And this is more or less the landscape we've operated in ever since, with adequate and appropriate methods for obtaining informed consent remaining a perennially grey area, especially as clinical trials globalize and involve research subjects with vastly different cultural, linguistic and educational norms.Bibliography1. Marshall, Geoffrey, et al. "Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation." BMJ 2.4582 (1948): 769-782.2. Salgo v. Leland Stanford Jr. University Board of Trustees, 317 P.2d 170, 181 (1957).3. Natanson v. Kline, 350 P.2d 1093, 186 Kan. 393, 186 Kansas 393 (1960).4. Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).5. Faden, Ruth R., Tom L. Beauchamp, and Nancy M. King. "A history and theory of informed consent." (1986). Oxford University Press.6. Marston, Robert Q. "Medical science, the clinical trial and society." Hastings Center Report 3.2 (1973): 1-4.7. The New York Post, Allen M. Hornblum, Dec 28, 2013. NYC's forgotten cancer scandal8. MATTER OF HYMAN v. Jewish Hosp., 15 N.Y.2d 317, 206 N.E.2d 338, 258 N.Y.S.2d 397 (1965).9. Katz, Jay, Alexander Morgan Capron, and Eleanor Swift Glass. Experimentation with human beings: The authority of the investigator, subject, professions, and state in the human experimentation process. Russell Sage Foundation, 1972.10. Langer, Elinor. "Human Experimentation: New York Verdict Affirms Patient's Rights." Science 151.3711 (1966): 663-666.11. Goldby, Stephen. "Experiments at the Willowbrook state school." The Lancet 297.7702 (1971): 749.12. Krugman, Saul, Joan P. Giles, and Jack Hammond. "Infectious hepatitis: Evidence for two distinctive clinical, epidemiological, and immunological types of infection." Jama 200.5 (1967): 365-373.13. Is Serum Hepatitis Only A Special Type of Infectious Hepatitis? JAMA. 1967;200(5):406-407. doi:10.1001/jama.1967.03120180094017.14. Annas, George J., Leonard H. Glantz, and Barbara F. Katz. Informed consent to human experimentation: The subject's dilemma. Ballinger Pub. Co., 1977.15. Goldman, Louis. "The Willowbrook Debate." World Med 7 (1971): 23-25.16. Ingelfinger, F. J. "Ethics of experiments on children." New England Journal of Medicine 288.15 (1973): 791-792.More details on the journey to, the process of, and grey areas in informed consent available in these answers:* Tirumalai Kamala's answer to Do you believe placebos are morally permissible? Why or why not?** Tirumalai Kamala's answer to Should we have an international forum to resolve clinical trial mishaps?*** Tirumalai Kamala's answer to Is it true that Bill Gates faced trial in India for illegally testing tribal children with vaccines?Thanks for the A2A, Kritika Gupta.

What are the real risks and consequences of a centralised health data repository?

A centralized repository will make it infinitely easier:For insurance companies to discriminate against consumers with a simple code - much like the TSA uses S's to indicate a flyer is on the "no-fly" list or is a security risk.For the haves and have nots to be stratified in ways that continue to destroy the middle class and to eliminate health care for people of color and of lower financial and class status because they can't afford health care or preventive care.If Wikileaks has taught us anything, it's that any system can be hacked. Medical hackers working for insurance companies can hack into such systems in order to gain access to information for who knows what purposes.Companies who award credit scores can ruin a person's good credit based on a probability number that the person may become ill at some point. Credit reports are already used to deny people housing, employment and opportunities to earn a living wage. People whose credit is ruined by divorce, medical crisis or layoffs etc. are lumped in the same category as people who abuse and misuse credit and have criminal reasons for poor credit. HR directors routinely run credit checks to determine the "employ-ability" of individuals, as do landlords, finance companies and medical professionals offering payment plans.Entire sections of the country - such as the terminal cancer tri-angle in Virginia due to the high deposits of uranium in N. VA/VA beach etc from fertilizers leaching into the water table, can be tracked and more insurance coverage denied in high risk areas. Insurance rates are already determined by factors such as age, gender, weight, health habits (exercise, smoking, drinking, zip code etc). Adding criteria such as living in a high cancer area is not inconceivable.For there to be a rebirth of eugenics - albeit under a different, more politically correct name such as "Financial eugenics," or "Medical eugenics." The U.S. Government, who will administer a national health care data base is most certainly interested in a central database for research. After all:Sixty years ago the US government deliberately infected almost 700 hundred people, many of them mentally ill patients, with gonorrhea and syphilis as part of a medical testing program. The people, all Guatemalans, were infected without their knowledge or consent and are now suing the US government.It wasn’t the first time or the last time the government would experiment with deadly diseases on its citizens or the citizens of other countries, or on children. Age, race, health – nothing mattered really. And if someone hadn’t discovered the testing and blown the whistle on this testing, no one would have ever known.Prof Susan Reverby at Wellesley College discovered the Guatemalan testing records. She says the Guatemalan government gave permission for the tests.Reverby also did research on the Tuskegee experiment, where the US authorities measured the progress of syphilis in African-American men without telling them they had the disease or adequately treating it. What is heart breaking is that many of the nurses in this program were also black and participated in it knowing what was going on.The Tuskegee experiment ran from 1932 to 1972, with President Bill Clinton eventually apologizing for it.Big Pharmaceutical companies drive a lot of these tests – many of them overseas without the control, knowledge or oversight of any organization or government. Vanity Fair wrote an article about this practice recently. It’s a good read – and one that will and should scare you. Why? Lots of reasons.Vanity Fair wrote about Celebrex trials in other countries and the cover-ups pharmaceutical companies went to in order to hide the deadly truth. Not only did Pfizer suppress a study calling attention to the fact that people taking Celebrex are more likely to suffer heart attacks and strokes than those taking older and cheaper painkillers, but they denied they suppressed it!These aren’t one-time bad decisions. There’s a pattern of big pharmaceuticals deliberately dumping bad drugs, bad blood and killing people in the name of finding a drug they can profit from. They’re willing to falsify data, pay off doctors, make up statistics and skew results to do it.Bayer - remember that name? Yeah, the folks who make aspirin. They do more. They kill people deliberately too. The New York Times reported about how in the 80’s Bayer deliberately moved AIDS tainted blood to Europe and sold it there – ultimately killing thousands of hemophiliacs. They were having problems selling the blood in the US, and later Europe but kept on making and promoting it even after new product was available because the old product was cheaper to produce. Bayer, Abbott Labs and others recruited people from prisons and at risk populations to get the plasma to create their product. They couldn’t screen out AIDS at the time and knew the plasma likely carried the virus – but oh well. There was money to be made.Bayer bought Cutter Labs – a name you might not know. Cutter produced polio vaccines with LIVE POLIO VIRUS in the vaccine. According to Wikipedia: 40,000 children who received the vaccine developed abortive poliomyelitis (a form of the disease that does not involve the central nervous system), 56 developed paralytic poliomyelitis and of these 5 children died as a result of polio infection.In 2004/2005 Pharmaceutical lobbyists managed to pass a bill mandating the psychiatric testing and drugging of ALL school children – without parental consent. If your child is deemed ADHD, or depressed, or bi-polar (beginning in grade ONE!) then they are prescribed drugs and must take the drug or the parent could lose the child to protective services. Nightmare? You bet.Aren’t these random incidents? NO!!In this article and time line below from Health News Net you can see – trusting our government isn’t a smart thing. Their site, is awesome by the way:A History Of US Secret Human Experimentation3-25-31931 Dr. Cornelius Rhoads, under the auspices of the Rockefeller Institute for Medical Investigations, infects human subjects with cancer cells. He later goes on to establish the U.S. Army Biological Warfare facilities in Maryland, Utah, and Panama, and is named to the U.S. Atomic Energy Commission. While there, he begins a series of radiation exposure experiments on American soldiers and civilian hospital patients.1932 The Tuskegee Syphilis Study begins. 200 black men diagnosed with syphilis are never told of their illness, are denied treatment, and instead are used as human guinea pigs in order to follow the progression and symptoms of the disease. They all subsequently die from syphilis, their families never told that they could have been treated.1935 The Pellagra Incident. After millions of individuals die from Pellagra over a span of two decades, the U.S. Public Health Service finally acts to stem the disease. The director of the agency admits it had known for at least 20 years that Pellagra is caused by a niacin deficiency but failed to act since most of the deaths occured within poverty-striken black populations.1940 Four hundred prisoners in Chicago are infected with Malaria in order to study the effects of new and experimental drugs tocombat the disease. Nazi doctors later on trial at Nuremberg cite this American study to defend their own actions during the Holocaust.1942 Chemical Warfare Services begins mustard gas experiments on approximately 4,000 servicemen. The experiments continue until 1945 and made use of Seventh Day Adventists who chose to become human guinea pigs rather than serve on active duty.1943 In response to Japan’s full-scale germ warfare program, the U.S. begins research on biological weapons at Fort Detrick, MD.1944 U.S. Navy uses human subjects to test gas masks and clothing. Individuals were locked in a gas chamber and exposed to mustard gas and lewisite.1945 Project Paperclip is initiated. The U.S. State Department, Army intelligence, and the CIA recruit Nazi scientists and offer them immunity and secret identities in exchange for work on top secret government projects in the United States.1945 “Program F” is implemented by the U.S. Atomic Energy Commission (AEC). This is the most extensive U.S. study of the health effects of fluoride, which was the key chemical component in atomic bomb production. One of the most toxic chemicals known to man, fluoride, it is found, causes marked adverse effects to the central nervous system but much of the information is squelched in the name of national security because of fear that lawsuits would undermine full-scale production of atomic bombs.1946 Patients in VA hospitals are used as guinea pigs for medical experiments. In order to allay suspicions, the order is given to change the word “experiments” to “investigations” or “observations” whenever reporting a medical study performed in one of the nation’s veteran’s hospitals.1947 Colonel E.E. Kirkpatrick of the U.S. Atomic Energy Comission issues a secret document (Document 07075001, January 8, 1947) stating that the agency will begin administering intravenous doses of radioactive substances to human subjects.1947 The CIA begins its study of LSD as a potential weapon for use by American intelligence. Human subjects (both civilian and military) are used with and without their knowledge.1950 Department of Defense begins plans to detonate nuclear weapons in desert areas and monitor downwind residents for medical problems and mortality rates.1950 I n an experiment to determine how susceptible an American city would be to biological attack, the U.S. Navy sprays a cloud of bacteria from ships over San Franciso. Monitoring devices are situated throughout the city in order to test the extent of infection. Many residents become ill with pneumonia-like symptoms.1951 Department of Defense begins open air tests using disease-producing bacteria and viruses. Tests last through 1969 and there is concern that people in the surrounding areas have been exposed.1953 U.S. military releases clouds of zinc cadmium sulfide gas over Winnipeg, St. Louis, Minneapolis, Fort Wayne, the Monocacy River Valley in Maryland, and Leesburg, Virginia. Their intent is to determine how efficiently they could disperse chemical agents.1953 Joint Army-Navy-CIA experiments are conducted in which tens of thousands of people in New York and San Francisco are exposed to the airborne germs Serratia marcescens and Bacillus glogigii.1953 CIA initiates Project MKULTRA. This is an eleven year research program designed to produce and test drugs and biological agents that would be used for mind control and behavior modification. Six of the subprojects involved testing the agents on unwitting human beings.1955 The CIA, in an experiment to test its ability to infect human populations with biological agents, releases a bacteria withdrawn from the Army’s biological warfare arsenal over Tampa Bay, Fl.1955 Army Chemical Corps continues LSD research, studying its potential use as a chemical incapacitating agent. More than 1,000 Americans participate in the tests, which continue until 1958.1956 U.S. military releases mosquitoes infected with Yellow Fever over Savannah, Ga and Avon Park, Fl. Following each test, Army agents posing as public health officials test victims for effects.1958 LSD is tested on 95 volunteers at the Army’s Chemical Warfare Laboratories for its effect on intelligence.1960 The Army Assistant Chief-of-Staff for Intelligence (ACSI) authorizes field testing of LSD in Europe and the Far East. Testing of the european population is code named Project THIRD CHANCE; testing of the Asian population is code named Project DERBY HAT.1965 Project CIA and Department of Defense begin Project MKSEARCH, a program to develop a capability to manipulate human behavior through the use of mind-altering drugs.1965 Prisoners at the Holmesburg State Prison in Philadelphia are subjected to dioxin, the highly toxic chemical component of Agent Orange used in Viet Nam. The men are later studied for development of cancer, which indicates that Agent Orange had been a suspected carcinogen all along.1966 CIA initiates Project MKOFTEN, a program to test the toxicological effects of certain drugs on humans and animals.1966 U.S. Army dispenses Bacillus subtilis variant niger throughout the New York City subway system. More than a million civilians are exposed when army scientists drop lightbulbs filled with the bacteria onto ventilation grates.1967 CIA and Department of Defense implement Project MKNAOMI, successor to MKULTRA and designed to maintain, stockpile and test biological and chemical weapons.1968 CIA experiments with the possibility of poisoning drinking water by injecting chemicals into the water supply of the FDA in Washington, D.C.1969 Dr. Robert MacMahan of the Department of Defense requests from congress $10 million to develop, within 5 to 10 years, a synthetic biological agent to which no natural immunity exists.1970 Funding for the synthetic biological agent is obtained under H.R. 15090. The project, under the supervision of the CIA, is carried out by the Special Operations Division at Fort Detrick, the army’s top secret biological weapons facility. Speculation is raised that molecular biology techniques are used to produce AIDS-like retroviruses.1970 United States intensifies its development of “ethnic weapons” (Military Review, Nov., 1970), designed to selectively target and eliminate specific ethnic groups who are susceptible due to genetic differences and variations in DNA.1975 The virus section of Fort Detrick’s Center for Biological Warfare Research is renamed the Fredrick Cancer Research Facilities and placed under the supervision of the National Cancer Institute (NCI) . It is here that a special virus cancer program is initiated by the U.S. Navy, purportedly to develop cancer-causing viruses. It is also here that retrovirologists isolate a virus to which no immunity exists. It is later named HTLV (Human T-cell Leukemia Virus).1977 Senate hearings on Health and Scientific Research confirm that 239 populated areas had been contaminated with biological agents between 1949 and 1969. Some of the areas included San Francisco, Washington, D.C., Key West, Panama City, Minneapolis, and St. Louis.1978 Experimental Hepatitis B vaccine trials, conducted by the CDC, begin in New York, Los Angeles and San Francisco. Ads for research subjects specifically ask for promiscuous homosexual men.1981 First cases of AIDS are confirmed in homosexual men in New York, Los Angeles and San Francisco, triggering speculation that AIDS may have been introduced via the Hepatitis B vaccine1985 According to the journal Science (227:173-177), HTLV and VISNA, a fatal sheep virus, are very similar, indicating a close taxonomic and evolutionary relationship.1986 According to the Proceedings of the National Academy of Sciences (83:4007-4011), HIV and VISNA are highly similar and share all structural elements, except for a small segment which is nearly identical to HTLV. This leads to speculation that HTLV and VISNA may have been linked to produce a new retrovirus to which no natural immunity exists.1986 A report to Congress reveals that the U.S. Government’s current generation of biological agents includes: modified viruses, naturally occurring toxins, and agents that are altered through genetic engineering to change immunological character and prevent treatment by all existing vaccines.1987 Department of Defense admits that, despite a treaty banning research and development of biological agents, it continues to operate research facilities at 127 facilities and universities around the nation.1990 More than 1500 six-month old black and hispanic babies in Los Angeles are given an “experimental” measles vaccine that had never been licensed for use in the United States. CDC later admits that parents were never informed that the vaccine being injected to their children was experimental.1994 With a technique called “gene tracking,” Dr. Garth Nicolson at the MD Anderson Cancer Center in Houston, TX discovers that many returning Desert Storm veterans are infected with an altered strain of Mycoplasma incognitus, a microbe commonly used in the production of biological weapons. Incorporated into its molecular structure is 40 percent of the HIV protein coat, indicating that it had been man-made.1994 Senator John D. Rockefeller issues a report revealing that for at least 50 years the Department of Defense has used hundreds of thousands of military personnel in human experiments and for intentional exposure to dangerous substances. Materials included mustard and nerve gas, ionizing radiation, psychochemicals, hallucinogens, and drugs used during the Gulf War .1995 U.S. Government admits that it had offered Japanese war criminals and scientists who had performed human medical experiments salaries and immunity from prosecution in exchange for data on biological warfare research.1995 Dr. Garth Nicolson, uncovers evidence that the biological agents used during the Gulf War had been manufactured in Houston, TX and Boca Raton, Fl and tested on prisoners in the Texas Department of Corrections.1996 Department of Defense admits that Desert Storm soldiers were exposed to chemical agents.1997 Eighty-eight members of Congress sign a letter demanding an investigation into bioweapons use & Gulf War Syndrome.© 1998-2000 Health News NetworkAll Rights ReservedBecause people will be fearful of being discriminated against for seeking medical care fewer people will get the treatment they need and we'll see an increase in things like tuberculosis and infectious diseases.Non-medical practitioners will have a field day - as will those holistic practitioners who heal with touch, herbs and supplements - meaning civil courts will be clogged as the industry and the criminal justice system seek to incarcerate and eliminate a hugely effective form of medical care.Some 80% of all diseases can be traced back to stress, childhood sexual abuse and poor diet and eating habits. Centralized repositories mean that individuals who change their diet, lose weight and achieve greater health after these changes will continue to be discriminated against because these repositories don't track HEALTH, they track illness.Women who have abortions may find their medical records become political time bombs - especially if they decide to enter public office. Because the medical records of our politicians are "open" - we'll all know if you had an abortion, have a history of sexually transmitted diseases, participated in an orgy in college and had to have a gerbil removed from your anus, were/are an addict, alcoholic or rape survivor. While not legally required to release their medical records, in today's political climate refusing to release such information to the public (media pressure) is tatamount to saying you have *something to hide* The issue of privacy when it comes to public figures, particularly if a mental illness or addiction is involved, is a moot point. Like their finances and personal relationships, voters believe they should have access to their leaders medical records and are fighting for The debate over whether Ronald Regan had Alzheimers while in office, or if Dick Cheney's heart was healthy enough to sustain the pressures of a term as president do concern voters. Given the mainstream media's almost obsessive fascination with the personal failings of everyone but their own - if you're an ordinary person and those files/records are hacked - the whole world will know your history - including depression, suicide attempts, physical exams and so on. If the media can't afford to expose your private records - someone will - as evidenced by Crivella West and MSNBC's willingness to pay to organize and host a digital data-base of Sarah Palin's emails while in office as the governor of Alaska.A history of not having all the required (and expensive) tests that the medical industry requires or recommends could put you at risk of not being approved for surgery or treatment of a disease. For instance, if you don't have a mammogram every other year, or you don't get a colon exam every year after 50 and you get cancer, you could be denied treatment for "failure to follow best practices."The list could go on and on...but remember, before you can globalize the world you have to globalize the countries in the world. We're well on our way to a one-world government. This is just another step in the process.

How important is CRISPR to gene-editing?

Here are two clippings (cut and pasted) from recent publication in Nature journal.First CRISPR babies: six questions that remainStartling human-genome editing claim leaves many open questions, from He Jiankui's next move to the future of the field.David CyranoskiThe CRISPR-Cas9 gene-editing tool is loaded into a pipette. Credit: Mark Schiefelbein/AP/ShutterstockThe meeting at which He Jiankui explained his extraordinary claim to have helped produce the first babies — twin girls — born with edited genomes came to a close with a statement that came down hard on the scientist.“We heard an unexpected and deeply disturbing claim that human embryos had been edited and implanted, resulting in a pregnancy and the birth of twins,” reads the statement released by the organizing committee of the Second International Summit on Human Genome Editing in Hong Kong on 29 November. “Even if the modifications are verified, the procedure was irresponsible and failed to conform with international norms."Similar criticism has rained down since the revelation earlier this week that He had used the CRISPR–Cas9 genome-editing technique to modify the CCR5 gene in two embryos, which he then implanted in a woman. The gene encodes a protein that some common strains of HIV use to infect immune cells.As researchers take stock of the week’s events, Nature summarizes six big questions that are still unanswered.1. Is He Jiankui in trouble?On 27 November, a day before He gave his talk at the summit, China’s national health ministry called on the government of Guangdong — where He’s university, the Southern University of Science and Technology is — to investigate He. Two days later, the science ministry ordered him to stop doing any science; He had already said the experiments were on hold. How the Guangdong investigation will proceed is not clear. He is accused of transgressing a 2003 health-ministry guideline, which is not a law and has no clear penalties attached to it.Whether He’s university will take any action against him is also unclear. A university spokesperson told Nature that he “cannot disclose such information at this moment” and to wait for official statements “at an appropriate time.” He has been on leave since February 2018 and this is scheduled to last until January 2021; this week, the university criticized his claims and distanced itself from his work.On 27 November, the laboratory web page hosted by the university — to which He has been referring people for information about the gene-edited babies — went down, although another site for He’s lab remains. Several statements praising He Jiankui’s accomplishments have also disappeared from government sites. A post on the science ministry’s site describing a genomic-sequencing technology that He developed, and a post praising He’s genomic sequencing technology on the website of the Thousand Talents Plan — a prestigious scheme to bring leading academics back to China — are both now inaccessible. It's not clear if these actions are related to the week's events, but both posts were still accessible until recently.He went back to Shenzhen, where he lives, after his talk at the summit, according to a statement provided by He's spokesperson, Ryan Ferrell, and missed a planned appearance at the summit on 29 November. “I have returned to Shenzhen and will not attend the conference on Thursday. I will remain in China, my home country, and cooperate fully with all inquiries about my work,” the statement said.2. Are He's claims accurate?Many scientists have said that an independent body should confirm He's scientific claims by performing an in-depth comparison of the parents’ and children’s genes. The problem is, almost everyone agrees that the babies and their parents should remain anonymous.“He has kept them secret, and for good reasons,” says Nobel-prizewinning biologist David Baltimore, chair of the summit's organizing committee and former president of the California Institute of Technology in Pasadena. “We haven’t even laid out how that independent investigation will happen.”He's team could supply anonymized samples. Outside scientists could also visit He's laboratory to analyse the data. In a statement released by his spokesperson, He said that he will invite other researchers to do an independent investigation. “My raw data will be made available for third-party review."He also says that he has submitted studies on his human gene-editing research to journals for publication. He has told some scientists that a paper will be published by the end of the year, but has not specified in which journal. But even if this happens, strict Chinese genetic-resources laws would prevent He from publishing the gene sequences of the parents or the children, and without those, scientists would have a difficult time verifying his claims.3. How exactly did CRISPR edit the twins' genomes?In the absence of a peer-reviewed publication or preprint describing He’s gene-editing work, some scientists are parsing his presentation to try and understand how the twins' genomes were edited — and any potential consequences of these changes.Gaetan Burgio, a geneticist at Australia National University in Canberra who works on CRISPR gene editing, says that the raw sequencing data that He presented in his talk suggests that the babies’ cells harbour multiple edited versions of the CCR5 gene, with different-sized DNA deletions. Such ‘mosaicism’ can be caused when CRISPR edits some early embryo cells differently to others, or fails to edit some. Other researchers have reported mosaicism in efforts to edit human embryos for research purposes.RNA researcher Sean Ryder, at the University of Massachusetts Medical School in Worcester, pointed out additional concerns in a Twitter post.He Jiankui told the gene-editing conference that he targeted the CCR5 gene because some people naturally carry a mutation in CCR5 — a 32-DNA-letter deletion known as delta-32 — that inactivates the gene. But Ryder says that that the CCR5 deletions that He claimed to introduce into the babies’ cells by CRISPR gene editing are not identical to the delta-32 mutation. “The point is that none of the three match the well-studied delta 32 mutation, and as far as I can tell, none have been studied in animal models. Unconscionable,” Ryder wrote in the post.He Jiankui claims to have helped produce the first babies born with edited genomes.Credit: TPG via Zuma4. When will there be another gene-edited human?As Jennifer Doudna, a pioneer of the CRISPR-Cas9 genome-editing tool, listened to He present his work at the summit, one idea kept coming back to her. “The thought I kept having was the potential for rogue scientists to use this in unethical ways. It’s a real risk,” says Doudna, a biochemist at the University of California, Berkeley,Before He’s revelations, many scientists were already worried about the prospect that someone was on the brink of creating a gene-edited person. Biologist George Daley, dean of Harvard Medical School in Boston, Massachusetts, and a member of the summit's organizing committee, pointed to a procedure that replaces diseased mitochondrial DNA in an embryo with healthy mitochondrial DNA from another person, eliminating the embryo's original disease-causing mutation. Although mitochondrial-replacement therapy lacks the approval of the biomedical community or the US Food and Drug Administration (FDA), doctors based in New York City used it to produce a baby in Mexico in 2016. “Similar premature practice of embryo editing by CRISPR-Cas9 is likely despite our calls for caution,” Daley said.At the Hong Kong summit, scientists discussed whether another announcement of human-germline editing — the modification of genes passed on to future generations — is nigh. “We do have reason to be concerned,” said Baltimore. “If anyone working in the field gets indications that it is happening, it is important they let authorities know.”5. Will He's revelations hamper ethical efforts to do germline editing?Many researchers fear that He's revelations could hamper the future of germline editing. “In the US some are suggesting draconian bans, which is antithetical to goals of science,” says Baltimore.In the wake of the revelations, FDA Commissioner Scott Gottlieb made comments that raised concerns among scientists. “Governments will now have to react,” he told the news site BioCentury. And on 28 November, the US National Institutes of Health (NIH) director Francis Collins said in a statement that “the need for development of binding international consensus on setting limits for this kind of research, now being debated in Hong Kong, has never been more apparent.”The statement released at the summit’s close makes a plea to keep open a path for safely translating gene-editing technology into treatments: “Germline genome editing could become acceptable in the future if these risks are addressed.”But the debacle has focused worldwide interest on germline genome editing and fears of a chilling effect may be overstated. “There might be some women excited by the possibility of taking part in this research,” said Judith Daar, at the University of California Irvine School of Medicine and School of Law, at a summit satellite session when asked whether the controversy might dissuade women from donating eggs for research in the future. “The instinct is to say this is a debacle and could suppress participation. But I’m always amazed by the diverse reactions," she added.6. How will scientists ensure better oversight of germline editing in future?“We don’t have a blueprint, but we have been asking academies,” said Baltimore. “It is a challenge to the world.”The statement released by the summit's organizing committee suggests that science academies around the world make recommendations to their own governments, while coordinating with each other.It also suggests the creation of an international forum that would funnel research and clinical trials through an international registry, and discuss issues such as equitable access to the benefits of gene editing. But genome editing in human embryos potentially has an unwieldy range of users, and that could make maintaining such an organization difficult. “Virtually every lab doing molecular biology is using this technique,” said Daley.The committee also suggested the need for a “translational pathway” that would provide a rigorous and responsible way for researchers to take germline gene editing to the clinic. Organizing-committee member Alta Charo, a bioethicist at the University of Wisconsin Law School in Madison, said expectations have to be realistic. “You can’t expect perfection. What you can do is try to minimize these incidents with enforcements that punish rogue behaviour.”The next human genome-editing summit will take place in London in 2021.doi: 10.1038/d41586-018-07607-3Additional reporting by Ewen Callaway.………………………………………………………………………………………………………….2. NEWS12 December 2018Baby gene edits could affect a range of traitsGene targeted for its role in HIV is linked to increased severity of other infectious diseases — and has implications for learning in mice.David CyranoskiHe Jiankui speaks about his claim to have helped make the first genome-edited babies.Credit: S. C. Leung/SOPA Images via ZumaChinese scientist He Jiankui’s extraordinary claim two weeks ago that he had helped to make the first babies — twin girls — with edited genomes shocked the world. Many questions remain about the experiments, but among researchers’ chief concerns are the potential effects of the genetic alterations on the girls’ health.He, a genome-editing researcher at the Southern University of Science and Technology of China in Shenzhen, says in several YouTube videos that he impregnated a woman with embryos that had been edited to disable a gene that allows HIV to infect cells. He targeted this gene, known as CCR5, because it is well studied, and because its mutation offers protection against HIV infection, which still carries a significant social stigma in China.The CCR5 gene has been the subject of research since the mid-1990s, and has roles beyond HIV that scientists are just beginning to understand. Loss of CCR5 function increases the risk of severe or fatal reactions to some infectious diseases, for example, and has also been shown to enhance learning in mice.Target geneThe CCR5 protein is expressed on the surface of some immune cells, and HIV takes advantage of it to sneak into the cells. In 1996, scientists identified a mutation, known as CCR5-Δ32, that makes carriers highly resistant to HIV1.Last month, He told a meeting of genomics researchers in Hong Kong that this is the mutation — found naturally in about 10% of Europeans — that he intended to produce in the twins. Scientists analysing his presentation slides say that, instead, He seems to have produced three different mutations in the girls. It is expected that these mutations will have disabled the gene, says Kiran Musunuru, a geneticist at the University of Pennsylvania in Philadelphia. Slides from He's presentation suggest that both copies of the gene were disabled in one of the twins. The other twin seems to have at least one working copy.Although the CCR5-Δ32 mutation disables the gene and makes carriers resistant to the dominant strain of HIV, over the past two decades dozens of studies have shown that CCR5 also helps to protect the lungs, liver and brain during some other serious infections and chronic diseases.It has a well-established protective role is in West Nile virus, which is transmitted by mosquitoes and is common in Europe, Africa and the Americas. Although most people infected exhibit no symptoms, about 20% do, with some developing potentially life-threatening complications such as meningitis or encephalitis. Philip Murphy, an immunologist at the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, has done experiments that show that people without a functional CCR5 gene are four times more likely than those with the gene to develop these serious conditions2. “CCR5 deficiency is not benign,” he says.Murphy says that the twin with one copy of the gene should be protected from these severe effects if she contracts the virus, but the other twin probably has a higher risk of complications if infected.Virus protectionWest Nile virus is rarely found in China. But the CCR5 protein also interacts with proteins called β-chemokines that help the body mount an immune response against a group of viruses called flaviviruses. These include tick-borne viruses, and the viruses that cause dengue and yellow fever, as well as West Nile virus, says Marcus Kaul an immunologist at the University of California, Riverside.Studies have found that people with the CCR5-Δ32 are more likely to experience severe encephalitis from tick-borne diseases, and to have a severe reaction to the vaccine for yellow fever.7“The absence of CCR5 can have severe disadvantages,” says Kaul.Influenza could also pose a greater risk to the twins . Work in mice has shown that the CCR5 protein helps to recruit key immune cells to fight the virus in the lungs3. Without the gene, this defence system fails. A study in Spain found that that people with the CCR5-Δ32 deletion are four times more likely than average to die from influenza4. And China is a hotspot for influenza outbreaks.Scientists have also found that, among people with multiple sclerosis, those with the CCR5-Δ32 deletion are twice as likely to die early than are people without the mutation5. What role CCR5 might have in other chronic conditions, such as hepatitis C and diabetes, is unclear — studies differ on whether it helps, harms, or makes no difference to these conditions.But, on the basis of the information in the consent form, none of these effects seems to have been communicated to the parents of the girls, or to other couples that participated in He’s experiments. He’s informed-consent procedure “was a disaster”, says Megan Allyse, a bioethicist at the Mayo Clinic in Rochester, Minnesota.He has not responded to Nature’s multiple requests for comment.Brain enhancement?Some studies have shown that defective CCR5 can have a positive effect — at least in mice. Mice without the gene learned to both navigate mazes and remember painful stimuli faster than rodents with the gene6. Overall, deletion of the gene improved the animals’ cognition by 30–60%, says Kevin Fox, a neuroscientist at Cardiff University, UK, and a co-author on the study. “It was a clear and large effect,” he says.Although Fox wonders whether the twins will learn faster than they would have done without the mutation, other scientists doubt that the gene deletion will have a noticeable effect on the girls’ learning. Hundreds, and possibly thousands, of genes contribute to intelligence in humans, says Kevin Mitchell, a geneticist at Trinity College Dublin. And the effect seen in mice might not translate to humans. The mutation might even have a negative effect on cognition, Mitchell says — for example, if it accelerates memory formation but makes it difficult to filter out unimportant memories. “Even if this mutation did have a cognitive effect in humans as in mice, which is not a given, it does not mean it would be a good thing,” says Mitchell.Silva Alcino, a neuroscientist at the University of California Los Angeles and Fox's co-author, agrees that any effect will likely be unpredictable. “In neuroscience the deletion of this receptor confers some advantages and very likely also results in deficits in some forms of cognitive function,” he says.Murphy thinks that despite the growing body of research on the mutation, it is difficult to draw conclusions about its overall effects. Only a small number of people have the mutation, making it difficult to recruit large numbers of participants for studies. However, the potential consequences of lacking a working CCR5 gene are probably greater than we have established so far, says Murphy. “What we know may be the tip of the iceberg,” he says.doi: 10.1038/d41586-018-07713-2NEWS12 December 2018Baby gene edits could affect a range of traitsGene targeted for its role in HIV is linked to increased severity of other infectious diseases — and has implications for learning in mice.David Cyranoski

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