Academic Misconduct Letter Sample: Fill & Download for Free

The push for higher academic achievement first made headlines in 1957 after Russia launched Sputnik ahead of the U.S. This goal might have been reached easily and efficiently had those in charge confined themselves to giving our already successful system a few tweaks, additions and/or enhancements.Instead, apparently based on the faulty premise that “new” equals “better,” the powers-that-be brought in new ideas to replace much of the curriculum and methodologies which had been working prior to 1966. As one reform idea after another failed to improve K-12 education, America’s educational system fell into an abyss of low academic achievement and, at times, functional illiteracy, for over 40 years.Consequently, like weeds that return every year, the same laundry list of issues has comprised the public and political debate about what’s “wrong” with our education system for the last 30 years. This laundry list of the problems to solve, which includes such issues as the achievement gap between whites and some ethnic groups, absenteeism, a 49-year history of lower test scores, too many drop-outs, too little technology, an absence of school choice, and a host of other factors deemed relevant to a good education, can mean only one thing: the country’s most recent reform movement appears to be headed down the same erroneous path taken in the mid-1960s.But, when one delves a little deeper, it becomes apparent that those issues are actually symptoms of what’s really wrong. For something to be identified as “wrong” with our entire education system, it must be (a) systemic, affecting every school district and (b) prevent the adequate resolution of the symptoms that comprise that laundry list of issues and problems.The only two elements that are systemic enough to meet this criteria are as follows:that every aspect of the post-1966 reform movement at every grade level is being controlled by politicians and other non-educators who lack the classroom experience necessary for making effective reform decisions which meet the needs of teachers, students and principals and that their reform decisions and actions may or may not involve the trading of favors so that friends, family and/or others may benefit financially from those reform decisions, and;a failure at every level to properly and adequately define the problems, which, given the school system’s earlier success, must begin with a comparison of pre- and post-1966 curriculum and methodologies, along with an examination of the academic outcome of subsequent reforms to determine (a) what was working before reforms pushed the system off the rails and (b) why those subsequent reforms not only failed to improve students’ academic performance but actually caused a decline in said performance that fell below pre-1966 levels (https://en.wikipedia.org/wiki/SAT#1928_and_1929_tests).REFORMERS' LACK OF EXPERIENCE/KNOWLEDGE -- It’s baffling that those given control over improving K-12 education actually lack the knowledge and experience necessary to make decisions about effective improvements. That this is offensive and insulting goes without saying. But, the potential for their decisions to have a devastating, and sometimes damaging, effect on the education and development of countless children who deserve the best renders their lack of knowledge and classroom experience downright dangerous.Even worse is the apparent refusal of these politicians and their non-educator cohorts to recognize that they have an obligation to compensate for the gaping hole in their ability to make effective decisions by eliciting input from teachers and principals. Inherent in this obligation is their ethical duty to address those needs with their reform decisions. Their failure to do so the last 40+ years represents a blatant, inexcusable disregard of their primary goal...the best interests of the students and, though we're not qualified to make any further determinations, it is worth noting that these actions may rise to the level of a misfeasance...misconduct which causes injury to another...or nonfeasance...the omission of an act that a person ought to do...or both for those acting in an official capacity within the confines of the official positions many of them hold.That these non-educators believe they’re capable of deciding what's best for over 70,000 school districts with myriad needs...without input from experienced educators...is absurd, ridiculous and self-serving. That they continue to maintain such a cavalier attitude toward the best interests of our children and grandchildren is unthinkable.One of the more recent examples of their ill-conceived ideas being promoted nationally as THE answer to improving education is school choice. Personally, I don’t know which is more absurd...the notion that it's logistically feasible to give everyone a choice of schools or the statement used to justify it.Though there's no evidence supporting school choice, think tanks, like Florida's Foundation for Excellence in Education ("ExcelinEd"), are pushing for it in reliance of the words of Joel Klein, a former NYC prosecutor and chancellor of schools in NYC, who claims “[t]he number one way to get a parent involved in a kid’s education is to give her a choice for her children.” ExcelinEd believes “all children can thrive when they are given the opportunity to choose the learning options best suited to their individual needs.” At best, this is an extremely careless statement, because children are NOT able to describe their "individual needs" nor choose among myriad "learning options."Proponents also believe choice will promote competition which will entice and inspire the improvement of poor-performing schools. The Texas Public Policy Foundation says: “Instead of repeating the same mistakes of the past, it’s time to implement what works well in other markets: Competition through school choice.” All this sounds good in theory. Rhetoric usually does. However, whether their goal is parental involvement or competition to entice the improvement of poor-performing schools, or both, their premise relies on the veracity of the following implications for each school district:each school has a choice about whether to be a good or bad school;some schools must remain low-performing to make having a choice possible and relevant;all the better schools have the physical space and staff to accommodate an influx of possibly hundreds of additional students;some, most, many or all districts do not intend to improve all their schools, so there will always be a choice between good schools and inferior schools.it is feasible for districts to meet any contractual responsibility for transporting hundreds, even thousands, of students to the better schools at varied distances;poor-performing schools won't ever want to improve unless they fear losing students to the better schools;all the parents who want the best education for their children won't respond to being advised their involvement is critical to achieving a quality education, so they have to be "forced" to become more involved in the process by an outside factor;giving parents a choice as to which school their children attend, by itself, involves those parents in their education in meaningful ways.each school is a separate, autonomous entity with control over which teachers, principal, curriculum and methodologies it chooses to employ.Possibly the best example of school choice is the program New Orleans began in 2006 as part of its district-wide reformation. They had significant problems until 2011 when the program was centralized for greater transparency and efficiency (The State of Public Education in New Orleans: Ten Years After Hurricane Katrina p.16). After nine years of school choice in a system where inferior schools are closed, only 89% of schools participate, only 84% of students are being served, only 75% of students are assigned one of their top three choices, last year only 61% were assigned to their top choice, and, lastly, there's nothing to indicate to what degree students' improved academic performance is the result of school choice, if at all.New Orleans' experience illustrates that "school choice" is not the panacea reformers and Joel Klein expect it to be. Thus, we can complete the analysis begun above by asking ourselves two questions: does the viability of "school choice" as an option for improving K-12 education in over 70,000 school districts require that the above-noted factors be true and feasible, and 2) are the above-noted factors true and feasible? Absent other relevant factors that haven't been considered here, it is clear that, for school choice to be a viable option, these factors must be true and reasonably feasible which, clearly, they are not.Yet, in spite of the obvious conclusion that there is no valid basis for instituting nationwide school choice to improve education, the powers-that-be are currently trying to force that option on every school district in the country. All this begs the question: what is their real agenda?DEFINING THE PROBLEMS -- Also baffling is the inability of today's reformer to recognize the degree to which all efforts to reform K-12 education are hindered by their failure to accurately define not just any problem but the correct problem(s). Higher standards, better trained teachers, better principals, and more involved parents are all well and good, but not even a gazillion reforms will have the desired impact if the real problems aren’t first identified and defined.Anytime change is desired, particularly change that's expected to result in improvement, one must first know in which direction to go by identifying and defining specifics...what needs changing; why does it need changing; which change offers multiple benefits and/or resolves the most issues; was there ever a time when it was better; if so, what was different then? Without the definitions that answer these questions, it’s impossible to know what changes should be made and how those changes should be implemented. Increasing the amount of homework HS students receive doesn’t improve anything if that doesn’t address the underlying reason for their declining performance over the years.The lower academic performance that, according to news reports, is of the greatest concern is that which is measured by standardized tests, including the SAT. Some say a comparison to pre-1966 scores isn't valid, because test scores since then have decreased because of a significant increase in the number of test takers who are considered disadvantaged economically and academically and, thus, lower-performing. But, that fact is effectively cancelled by the fact that pre-1966 tests, especially the SAT, were significantly more difficult, calculators were not permitted, and there were no prep courses available. In fact, the sample test I took in October, 2015, was shockingly easy, and the March, 2016 SAT is being promoted as even easier. Thus, the more relevant question is, given the changes over the years that made the SAT easier, for example, why haven't scores improved, or at least remained at pre-1966 levels?Answering that question first requires a review of standardized tests. From the little I've seen, these tests still are predominantly reading comprehension tests, including the math, which includes word problems. That’s a language skill. Therefore, though a lack of knowledge contributes to lower scores, the primary reason has to be underdeveloped language skills...reading comprehension, cultural literacy and vocabulary.Since K-6 education is all about developing basic language and math skills, reform should focus first and foremost on K-6 curriculum and methodologies being used and what, if any, changes should be made. Inasmuch as studies show that SAT scores fell below pre-1966 levels, K-12 education prior to 1966 was more effective than reforms implemented since then. Therefore, re-implementing the pre-1966 curriculum and methodologies will improve academic performance for all grades, even if no other changes are made to the K-12 system.Fortunately, since some of those who received a superior K-6 education prior to 1966 are still alive, we know what was being done in their K-6 classrooms. Specifically, along with a harder K-12 grading system and 6th grade being the last grade in elementary school, the pre-1966 K-6 education included phonics to teach reading, sentence diagramming to teach comprehension and sentence construction, use of the original method for teaching basic math, daily recess, and NO HOMEWORK.Implementing these changes do not need to represent the sum total of reform, but they must be the first step, because, without them, all other reforms at every grade will be pointless. Once these changes are solidly in place, other reforms can be added gradually. As explained above, this approach is both based on, and proven valid by, the fact that post-1966 reforms that replaced this curriculum and methodology resulted in a decrease in test scores, which is supported by subsequent subject-specific studies.PHONICS...... “Give a man a fish, he eats for a day; teach a man to fish, he eats for a lifetime.” Phonics does for reading what teaching a man to fish does for his survival. Unlike the Whole Language and Look-Say methods that give students their fish for a year or two or three, phonics gives students the skills to read brand new words for a lifetime. After Whole Language resulted in dismal test scores in California, "Newsweek" reported that "most research backs the need for lots of phonics, the sooner the better," and "Time" did its own review "and concluded that evidence supporting "...phonics...is "so strong that if the subject...were...mumps, there would be no discussion." The evidence is overwhelming that “[p]honetically based reading instruction (explicitly teaching children the letter-sound relations and how to use ‘sounding out’ strategies to read unfamiliar words) is more effective than less systematic approaches" (Page on nih.gov 4538787 and cites therein). To this instruction should be added opportunities for “hearing and reading wonderful literature.” (Ravitch, Diane, The Death and Life of the American School System, Perseus Books Group, Phil., PA, 2010, p. 232; also p. 443-452).SENTENCE DIAGRAMMING.....From the articles I've read, this method of instruction has been getting a bad rap, as they say, because people misunderstand its function and purpose. Its primary function is not to teach grammar, which is why it's introduced in 4th grade, after lessons in grammar, instead of first grade.Sentence diagramming is used to teach sentence construction and is particularly useful in teaching the construction of complex sentences. If it aids a student's understanding of grammar, it's in relation to the placement of those words in a sentence. What makes this method so helpful in learning to write is that, in learning to see sentences as comprised of separate components, the child develops an instinct for how to combine words and phrases to construct complex sentences correctly, which helps develop the ability to recognize the varied ways in which the same thought can be expressed. It also aids in determining the correct placement of punctuation, especially commas.While the benefit of using sentence diagramming to teach writing might be fairly obvious, what isn't as obvious is its ability to improve reading comprehension skills. What makes it so effective as a tool for teaching reading comprehension is the fact that it trains a child’s brain to see the separate components of a complex sentence, how those components relate to each other to convey a specific message, and what happens to that message if the placement of one or more phrases is changed.I can't speak for other countries and other cultures, but Americans seem to underestimate the unusual but beneficial ways in which the human brain can be trained to perform certain functions faster or more effectively. For instance, learning and playing chess trains the brain to think long-term by considering a variety of "what-if" scenarios. The best way to train the brain to listen and taken excellent notes is to spend a semester or two taking a shorthand or speedwriting course. Sound silly? Maybe, but it works better than any other method, because your brain becomes capable of writing one thing while hearing another. These are just two examples of the way an unexpected activity can have an unusually beneficial effect on the brain.MATHEMATICS........After the failure of the "new math" that stressed math as conceptual rather than computational and a refusal to accept the rote drilling of the back-to-basics movement that followed, the 1990s brought new standards by the National Council of Teachers of Mathematics which, based on the belief that "basic skills had been rendered obsolete by calculators," focused on "student-led activities, math games, working with manipulatives (e.g. blocks and sticks), using calculators and group learning and discounted the importance of correct answers." But, this "fuzzy...new, new math" also failed, because, as critics insisted, "students [can] not learn higher-order skills if they [do] not first possess basic skills." Ravitch, Diane. Left Back: A Century of Battles Over School Reform. Touchstone, NY, NY. 2000, p. 438-440.All the post-1966 math reforms have one thing in common: a focus on student-centered learning dependent on students' activities instead of teacher-led learning dependent on teachers' directions. (Ibid. p.441)With the reforms, “students are supposed to think deeply, work collaboratively, and discover their own ways of solving problems” which should include more than one solution except “students who don’t have a firm grasp of basic arithmetic are seldom able to find their own solutions.” Ravitch, Diane, The Death and Life of the American School System, Perseus Books Group, Phil., PA, 2010, p. 41-42). How could anyone ever think it makes sense to tell students the correct answer isn't that important when, in the real world, the correct mathematical answer is everything?RECESS/PHYSICAL ACTIVITY....There have been a number of studies showing that “physical activity affects metabolism and all major body systems, exerting powerful positive influences on the brain and spinal cord and, consequently, on emotional stability, physical health, and motivation and ability to learn.” Conversely, “...inactivity[,]” which is highly and disproportionately prevalent among...urban minority youth, has a negative impact on academic achievement through its effects on cognition...” Thus, “...a comprehensive approach that includes physical education [and] wise use of recess and after-school times...” is highly recommended. http://www.ncbi.nlm.nih.gov/pubmed/21923875; http://www.ncvi.nlm.nih.gov.pubmed/22070504; 22213750; 19149783; 19211963; 22260155 Clearly, physical activity does more to improve a child’s capacity for learning than years of homework ever could.At least one study has also shown “a beneficial association between exposure to green space and cognitive development among [primary] schoolchildren...,” which refers to the greenness of outdoor space in their environment...at home, school and during the commute to and from school. (Green spaces and cognitive development in primary schoolchildren.)NO HOMEWORK......Proponents of homework cite the need for children to learn time management skills, consequences, accountability, development of good study habits and skills, development of independent problem-solving skills, and greater self-direction and self-discipline. But, in so doing, they are not considering the ages of students. In this instance, I’m talking about children age 5-13. Many of these skills are developed through being assigned and completing chores at home. After 6th grade, they will have six years of homework to help them develop those skills. Inasmuch as studies show that physical activity improves their cognitive development, letting homework deny them that activity is actually harming their cognitive development.In addition, there are enough studies showing that, while there may be some benefit to assigning homework in the upper grades, the benefit to the primary grades is essentially zero and that “in-class study proved superior.” Kaleidoscope: Readings in Education, “Homework for All -- in Moderation” by Harris Cooper. Houghton-Mifflin Co., Boston, MA, 2004, p.252-257.If homework is assigned at all, it should be no more than 10 minutes X the grade level, so homework for 2nd grade should be no more than 20 minutes’ worth, 3rd grades should be no more than 30 minutes and so on. But, the need for physical activity in grades K-6 and the fact that prior to around 1966, K-6 students received a superior education with no homework should be evidence enough that K-6 education should NOT include homework.That lower scores on standardized tests are caused primarily by underdeveloped language skills also leads us to an unexpected cause and possible resolution(s) of the achievement gap between black and white students that goes beyond the results of the Shaker Heights study.Shaker Heights is a wealthy suburb of Cleveland where a study discovered that, though black parents and their children both care about performing well in school, neither was actually doing what it takes to do well. That is, parents "spent no more time on homework or tracking their children's schooling than poor white parents" and the students just "failed to put forth [the] effort." (Harvard Education Publishing Group - Home; Page on eastbayexpress.com)However, given my experience, though limited it may be, I'm compelled to question whether that is the final word on the subject. Just as various cultures and ethnic groups have a preference for certain routines, traditions, foods and the like, during my first experience teaching inner-city students, I observed that they prefer to speak to each other in phrases and various versions of incomplete sentences rather than complete and complex sentences, and they also have a tendency to incorrectly use key words that are similar to the word they thought they were using. Though curious about what this might mean, if anything, I didn’t pursue it further until many years later when, thanks to the candor of a student, I realized their communication style may have a relevance no one had considered before this.After many weeks of GED instruction in another state, one of my adult, black students told me that she loves coming to class to listen to me speak, because she finds it so inspiring, BUT...with a bit of a sigh...”It gives me a headache!”I knew instantly what she meant. I speak in sentences and paragraphs and often use complex sentences. She was telling me that it’s too much information, and her effort to absorb and understand it all, which she sincerely wanted to do, was such a struggle that, quite naturally, it gave her a headache. I’d always assumed (how often is that a mistake!) that explaining a concept or a definition two or three different ways was aiding their understanding, in part, because it had always aided my understanding when I was a student. But, for someone who grew up communicating in phrases and partial sentences which only required listening for key words to aid understanding, the voluminous amount of information and verbosity coming out of my vocal orifice would have been beyond overwhelming. Golly, I would have given me a headache, too!That confession combined with my earlier observations formed a premise that may help explain the lower performance of my urban students and the lower performance of some or many urban, black and/or disadvantaged students in our public schools. And, like any good definition of a problem should, it points toward what needs to be done to overcome its negative effects on the development of the language skills necessary to improve their academic performance.Since there don’t appear to be any studies in this area, I must stress that this assessment is my own based on my professional experience as a predominantly post-secondary teacher of mostly urban and black adults in two northern cities. I must also stress that I do not presume to know how many students and families may or may not find this relevant to their particular situation. In the absence of studies that many of us believe should precede the consideration of any notion or theory, some folks may consider this a totally off-the-wall, out-in-left-field premise. As an initial reaction, that's fair. But, it's also fair that it be given serious consideration for the sake of the millions of children who are much more intelligent than their performance indicates.And, since it could be better explained by someone with training in linguistics and/or neurology, I apologize for my clumsy attempt to do so here. In rather elementary, crude terms, the premise is that children who grow up in and live in an environment where the communication style involves short phrases and a reliance on key words to aid understanding may enter school with a short attention span and without a strong ability to listen to all those complete sentences being spoken and read by the teacher. Unable to understand much of what they hear, in turn, hinders their ability to absorb the reading lessons. Without the use of phonics, their ability to learn is even more hindered.To be more specific, we know the brain is malleable. It’s also a muscle, and, like any muscle, it’s ability to perform at optimum levels improves with use and atrophies from lack of use. The more required of our brains, the more synapsis are formed over which more connections can be made between neurons. Because it is through those connections that our brains are able to do what they do...absorb new information and store it in memory..., the more connections we form, the better we function. Therefore, a child’s ability to learn and function depends on how varied, demanding, engaging and rich with experience and vocabulary and language that child’s daily environment is.As an example, though the cooing and ahhhing of baby talk is great fun for parents and their infant children, the parent who reads extensively to a baby and speaks extensively using complex sentences and paragraphs is forcing that baby’s brain to form synapses over which many new neurons can be connected in preparation for learning to speak the language the infant is hearing every day. And, though children learn language in various ways, what’s common among all children is that from the moment of birth, the brain begins soaking up information about all the rules of language, such as tone, inflection, rhythm, word connections and relationships, speech patterns; grammar rules, such as when to add “e-d” to a word; nouns and verbs; and so on.As to its effect on listening, what I’ve noticed with my students is that they will hear unfamiliar or vaguely familiar terms without fully hearing them. They might hear the ending of a word and the first letter of the word, for instance, and have a vague idea of its meaning, but their brains don’t quite catch every detail of the rest of the word. Then, when they try to use at another time, the word that comes out is an incorrect word that sounds like or resembles in some way the word they think they’re saying.As an example, a black actress on a TV show attempted to describe how someone else smelled when he showed up late for filming after smoking marijuana. She said that "he permeated” marijuana when she wanted to say that the marijuana emanated from all over him or that it "permeated the room." These little glitches in communication have nothing to do with intellect. This actress is a very intelligent person. Others who make similar mistakes are also as intelligent, or more intelligent, than everyone else. I suspect it’s a glitch in listening that results from a certain type or style of communication. It's not that there's anything particularly wrong with this communication style. Obviously, it works well for those who use it or they wouldn't bother with it. It's just that it appears to hinder the children’s ability to master language at an advanced level.The advantage white students have over black students is not just that their parents may read to them more; it's that white parents, in general, talk to their children in sentences and paragraphs from the day they're born. From its first day of life, that child's brain is developing connections that will make it easy to eventually understand all that lengthy conversation with its complex sentences. This means, of course, that teachers cannot make any assumptions about the inherent ability and apparent progress of their urban, black, and socioeconomically disadvantaged students, because, once they’ve improved their language skills, they will, undoubtedly perform academically at the same level as their white peers or better.While there can always be other factors affecting a particular child’s academic performance on any given day, absent sufficient proof to the contrary, it is reasonable to presume that students will be helped greatly by the education community accepting and addressing the only facts currently available: that the “achievement gap,” about which there has been so much outcry, has two primary causes: disengagement in the learning process by black students and their parents (explained in greater detail in the articles about the study) and the culture's preference for speaking in phrases which, in the crude terms of one not trained in neurology, tends to prevent the development of the neurological connections necessary for a longer attention span and the ability to listen, comprehend and form complex sentences. And, though an experienced K-6 teacher can speak more directly to resolutions, it seems likely that overcoming this barrier may only require devising some specific teaching methodologies.So, all things considered, when this question is analyzed absent the emotional investment everyone seems to have in the matter, it becomes apparent that most education reform issues, such as poor attendance, high percentage of dropouts, the achievement gap between black and white students, low test scores, and any other issue one can name, are only symptoms of the two more systemic issues described and defined above.It follows then that, until the above-described changes are implemented nationally in grades K-6 and those students graduate from elementary school and enter the upper grades with improved comprehension and writing skills, any reforms thrown at grades 7-12 will have little or no effect on academic improvement. The only way to improve that outcome by speeding up the academic improvement at every grade level is to give today's upper-grade (7-12) students special instruction to improve their language skills.

Because of our beliefs. THINGS ARE NEVER AS THEY SEEM TO BE.And how did we build our belief systems? Through a multitude of processes from the moment we were born up to each individual decision point that we either missed altogether or made a wrong decision.I once invested $7000 in a company called LeapFrog, a family business developing hardware and education software to make kids smarter. All business and trading fundamentals pointed to 9 out of 10 including zero debt. I also firmly believed that sales will go up as parents do want their kids o be smarter, and every year there will be more and more parents on the planet, and more children as well.And the stock went up in many months that followed. Mind you, I bought it at the lowest point in the past 52 weeks at that moment. I was in an incredibly good position as it is very rare that you buy a stock at the absolute lowest point. The stock reached $11000, maybe even $12,000 if I correctly remember. And I didn’t sell. I firmly believed. I remembered Amazon and similar and somehow thought LeapFrog will be a long-term winner as well.Long story short, the stock went down and as it reached $10000 level, I was remembering $11000 level and convinced myself that my long term strategy is still good and sound. But in many months that followed, the stock went down with occasional ups that are customary.At the end, the company was sold and the condition of the sale was that each shareholder gets $1 for each share (I bought it for 7 times that). I lost my own $6000 plus $4000 profit that I could close any time I wanted, if I had made a right decision. I.e. my total loss on this stock was exactly $10,000.THINGS ARE NEVER AS THEY SEEM TO BE.Another example from health field.Pushing children into suicide with happy pillsGlaxo study 329In 2001, GlaxoSmithKline published a trial in children and adolescents, study 329. 1 This study reported that Paxil (Seroxat) was effective with minimal side effects, and it was widely believed and cited, no less than 184 times by 2010, which is remarkable. However, the trial was fraudulent. We know this because the Attorney General of New York State sued the company in 2004 for repeated and persistent consumer fraud in relation to concealing harms of Paxil, 2 which opened the company’s archives as part of a settlement. Glaxo lied to its sales force, telling them that trial 329 showed ‘REMARKABLE Efficacy and Safety’, 3 while the company admitted in internal documents that the study didn’t show Paxil was effective. The study was negative for efficacy on all eight protocolspecified outcomes and positive for harm. These indisputable facts were washed away with extensive data manipulations, so that the published paper, which – although it was ghostwritten – had 22 ‘authors’, ended up reporting positive effects. 3,4 The data massage produced four statistically significant effects after splitting the data in various ways, and it was clear that many variations were tried before the data confessed. The paper didn’t leave any trace of the torture; in fact, it falsely stated that the new outcomes were declared a priori. For harms, the manipulations were even worse. The internal unpublished study report that became available through litigation showed that at least eight children became suicidal on Paxil versus one on placebo. This was a serious and statistically significant harm of Paxil (P = 0.035). There were 11 serious adverse effects in total among 93 children treated with Paxil and two among 87 children treated with placebo, which was also significant (P = 0.01, my calculation; the paper didn’t say that this difference was statistically significant). This means that for every 10 children treated with Paxil instead of placebo, there was one more serious adverse event (the inverse of the risk difference, 11/93 – 2/87, is 10). However, the abstract of the paper ended thus: ‘Conclusions: Paroxetine is generally well tolerated and effective for major depression in adolescents.’ An early draft of the paper prepared for JAMA didn’t discuss serious adverse effects at all! JAMA rejected the paper, and later drafts mentioned that worsening depression, emotional lability, headache and hostility were considered related or possibly related to treatment. The published paper did mention the serious adverse effects, but only headache in one patient was considered by the treating investigator to be related to paroxetine treatment. I have my doubts about whether the treating investigators really made these decisions. As the adverse events were reported to the company and appeared in earlier drafts, it’s more likely that it was people employed by Glaxo that interpreted the drug’s harms so generously. In the published paper, five cases of suicidal thoughts and behaviour were listed as ‘emotional lability’ and three additional cases of suicidal ideation or self-harm were called ‘hospitalisation’. At least three adolescents threatened or attempted suicide, but this wasn’t described in the paper. Its first author, Martin Keller, wrote that they were terminated from the study because of non-compliance. 2 There were other issues the published paper said nothing about. For one of the suicidal teenagers, the treating psychiatrist asked a researcher involved with the study to break the blind, which he refused although the protocol provided for this. Another ‘non-compliant’ teenager ingested 82 tablets of paracetamol, which is a deadly dose. Most curiously, another teenager was enrolled with the same trial number as the suicidal one, although this should be impossible, but perhaps the new patient took what remained of the study drug? This raises the uncomfortable question whether some patients who had fared badly were excluded from the trial. When the FDA demanded the company to review the data again, there were four additional cases of intentional self-injury, suicidal ideation or suicide attempt, all on paroxetine. Keller is some character. He double-billed his travel expenses, which were reimbursed both by his university and the drug sponsor. Further, the Massachusetts Department of Mental Health had paid Brown’s psychiatry department, which Keller chaired, hundreds of thousands of dollars to fund research that wasn’t being conducted. Keller himself received hundreds of thousands of dollars from drug companies every year that he didn’t disclose. A social worker found a computer disc in the hallway and opened it to see to whom she should return it. She realised that adolescents were listed as if they had been enrolled in a study, which wasn’t true. It seemed they were made up, which would have been tempting given that $25 000 was offered by the drug company for each vulnerable teenager. The president of a chapter of the National Alliance for the Mentally Ill, supposed to be a patient advocacy group but heavily supported by big pharma, lectured for patients and their relatives on drug company money, which he didn’t reveal, and the honoraria were whitewashed. 2 Keller never admitted there was anything wrong with the way he reported study 329. And his misdeeds didn’t harm his career. His department has received $50 million in research funding and a spokesperson from Brown said that ‘Brown takes seriously the integrity of its scientific research. Dr Keller’s research regarding Paxil complied with Brown’s research standards.’ Well, thanks for letting us know that, with such ethical standards, we should never apply for a job at Brown’s. The role of the journal, Journal of the American Academy of Child and Adolescent Psychiatry, was similarly depressing. Although the journal’s editors were shown evidence that the article misrepresented the science, they refused to convey this information to the medical community and to retract the article, thereby jeopardising their scientific standing and moral responsibility to prescribers and patients. 4 An explanation for this passivity can likely be found by following the money that goes to the journal’s owner. What caused the greatest public uproar was that Glaxo pushed its drug for use in children, although it not only didn’t work in children, it was also very harmful, and it wasn’t even approved for use in children. The illegal marketing involved withholding trials showing Paxil was ineffective. 5 An internal company document showed that the company knew what it was doing: ‘It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.’ 4 The ruthless marketing worked. From 1998 to 2001, five million prescriptions a year were being written for Paxil and Zoloft for children and adolescents. 6 We should remember that there are real tragedies behind the numbers and real people who have paid with their lives for the companies’ unscrupulous lies, frauds and crimes: 7 Matt Miller was unhappy. Having moved to a new neighborhood and a new school, Matt was thrust into unknown territory without his support system of old friends with whom he had grown up. That summer, Matt was prescribed Zoloft … and was told to call his doctor in a week. On a Sunday night, after taking his seventh pill, Matt went to his bedroom closet, where there was a hook just a little higher than he was tall. Matt hung himself, having to lift his legs off the floor and hold himself there until he passed out. He was only thirteen years old. Jeremy Lown, a teenager, suffered from Tourette’s syndrome. To treat his uncontrollable tics and verbal outbursts, his neurologist prescribed Prozac. Three weeks after starting the medication, Jeremy hanged himself in the woods behind his house. 8 Candace, a 12-year-old girl, was prescribed Zoloft because she suffered from anxiety. She was a happy child that had never been depressed or had suicidal ideation. She hanged herself after 4 days. 9 Vicky Hartman was given a sample pack of Zoloft by her child’s doctor. She didn’t suffer from any mental disorder but mentioned she needed a ‘pick-me-up’ to help with stress. Soon after starting the medication, she shot her husband and herself. 8 A man hanged himself after taking Prozac, which his cardiologist had prescribed for chest pain, and a woman shot herself after taking the Prozac her family doctor had prescribed for migraine. Twenty-year-old student Justin Cheslek had trouble sleeping and was prescribed sleeping pills by his doctor. 10 A few days later, he complained to the doctor that the pills made him feel groggy and ‘depressed’. The doctor gave him Paxil, and Justin told his mother that Paxil made him feel awful, wound up, jumpy and unable to sit still or concentrate. Two weeks later, the doctor gave him another SSRI, Effexor (venlafaxine), which caused a seizure after the first tablet. Justin still felt ‘really, really bad’ and 3 weeks after he took his first Paxil tablet, he hanged himself. Justin had no history of depression and if he hadn’t used the term ‘depressed’, he might not have been prescribed SSRIs. He just had trouble sleeping. In the days before his death, Justin described a feeling of wanting to jump out of his skin, a symptom typical of akathisia, which may lead to suicide. In November 2010, Nancy and Shaun McCartney’s 18-year-old son, Brennan, went to their family doctor with a chest cold. 11 The extroverted high school student mentioned feeling sad over breaking up with a girl he’d been seeing for 3 months. He left with a script for an antibiotic and a sample pack of Cipralex. Nancy expressed concern, as Brennan had no history of depression, but he assured her the doctor had said it would help. On the fourth day, Brennan seemed agitated when he left the house and he failed to come home. The next day his body was found. He had hung himself in a local park. Nancy wanted to warn other Canadians about Cipralex and submitted an adverse reaction report, and when she noticed a typo on her entry, she called the Vigilance Branch requesting a correction. She also asked for an updated copy but was told she’d have to file an access to information request. Seven months later, anyone searching Cipralex on MedEffect would find 317 reports, including five suicides, 12 suicide attempts and many references to suicidal ideation, but not Nancy’s submission. When the journalist writing about the tragedy asked Health Canada why, its spokesperson responded weeks later saying the entry was in the database and provided a screen grab. However, subsequent searches using the same terms failed to find it. It’s unbelievable. Not even suicides reported to the authorities may be traceable in their records. Here is an example that the advertising of prescription drugs to the public, which is legal in the United States, can kill healthy people who don’t need them: 12 Ten years ago my irrepressible teenage daughter Caitlin returned from holiday with relatives in the US, where prescription drugs are widely advertised; she saw an ad for an antidepressant drug called Prozac and wanted to try it. She went to our local GP and it took her 8 minutes to get the prescription. Sixty-three days later, during which time she descended into unprecedented chaos, including neural twitches, violent nightmares and self-harm, she hanged herself. Concealing suicides and suicide attempts in clinical trials I shall explore here what the true risks of suicide and suicidality with SSRIs are. They are certainly much larger than what the drug companies have told us. David Healy performed a study in 20 healthy volunteers – all with no history of depression or other mental illness – and to his big surprise two of them became suicidal when they received sertraline. 13 One of them was on her way out the door to kill herself in front of a train or a car when a phone call saved her. Both volunteers remained disturbed several months later and seriously questioned the stability of their personalities. Pfizer’s own studies in healthy volunteers had shown similar deleterious effects, but most of these data are hidden in company files. 13 FDA reviewers and independent researchers found that the big companies had concealed cases of suicidal thoughts and acts by labelling them ‘emotional lability’. 13,14,15 However, the FDA bosses suppressed this information. When safety officer Andrew Mosholder concluded that SSRIs cause increased suicidality among teenagers, the FDA prevented him from presenting his findings at an advisory meeting and suppressed his report. When the report was leaked, the FDA’s reaction was to do a criminal investigation into the leak. 16,17 There were other problems. In data submitted by GlaxoSmithKline to the FDA in the late 1980s and early 1990s, the company had included suicide attempts from the washout period before the patients were randomised in the results for the placebo arms of trials, but not from the paroxetine arms. A Harvard psychiatrist, Joseph Glenmullen, who studied the released papers for the lawyers, said that it’s virtually impossible that Glaxo simply misunderstood the data. Martin Brecher, the FDA scientist who reviewed paroxetine’s safety, said that this use of the washout data was scientifically illegitimate. 18 Indeed. I believe it’s fraud. David Healy wrote in 2002 19 that, based on data he had obtained from the FDA, three of five suicide attempts on placebo in a sertraline trial 20 had occurred during washout rather than while on placebo and that two suicides and three of six attempts on placebo in a paroxetine trial 20 had also occurred in the washout period. Healy’s observations weren’t denied by Pfizer and Glaxo, 21,22 but Glaxo again provided a glaring example that their lies are not of this world: 22 The ‘drug’ v. ‘true placebo’ analysis Dr Healy describes is not only scientifically invalid, but also misleading. Major depressive disorder is a potentially very serious illness associated with substantial morbidity, mortality, suicidal ideation, suicide attempts and completed suicide. Unwarranted conclusions about the use and risk of antidepressants, including paroxetine, do a disservice to patients and physicians. So, should we trust people who deliberately hide suicidal harms of their drug and hide trials that showed no effect and make billions out of their frauds, who are only responsible to their shareholders, and who nonetheless wants us to believe that patient welfare is their primary concern? Or should we trust an academic like Healy whose job it is to take care of the patients? At least three companies, Glaxo, Lilly and Pfizer, added cases of suicide and suicide attempts in patients to the placebo arm of their trials, although they didn’t occur while the patients were randomised to placebo. 13,19,23,24,25 These omissions can be important for the companies in court cases. For example, a man on paroxetine had murdered his wife, daughter and granddaughter and committed suicide, but in its defence, Glaxo said that its trials didn’t show an increased risk of suicide on paroxetine. 26 The pervasive scientific misconduct has distorted seriously our perception of the benefits and harms of SSRIs. As an example, a 2004 systematic review showed that, when unpublished trials were included, a favourable risk–benefit profile changed to an unfavourable one for several of the SSRIs. 27 Also in 2004, a researcher used the full reports of Glaxo’s trials that were made available on the internet as a result of litigation, and he found in his meta-analysis that paroxetine increased significantly suicidal tendencies, odds ratio 2.77 (95% confidence interval 1.03 to 7.41). 14 He included three trials, among them the unpublished study 377, which didn’t show that paroxetine was better than placebo (Glaxo had stated in an internal document that ‘There are no plans to publish data from Study 377.’) 28 He also included the infamous study 329. He described that an 11-year-old boy who threatened to harm himself and was hospitalised was coded as a case of exacerbated depression, and that a 14-year-old boy who had harmed himself and expressed hopelessness and possible suicide thoughts and was hospitalised was coded as a case of aggression. It is widely believed that SSRIs only increase suicidal behaviour in people below 25 years of age, but this is not correct. A 2006 FDA analysis of 372 placebo-controlled trials of SSRIs and similar drugs involving 100 000 patients found that up to about 40 years of age, the drugs increased suicidal behaviour, and in older patients, they decreased it (see Figure 18.1). 29 However, as explained below, it is much worse than this. A major weakness of the FDA study is that the agency asked the companies to adjudicate possibly suicide-related adverse events and send them to the FDA, which didn’t verify whether they were correct or whether some had been left out. We already know that the companies have cheated shamelessly when publishing suicidal events. Why should they not continue cheating when they know that the FDA doesn’t check what they are doing? Furthermore, collection of adverse events was limited to within one day of stopping randomised treatment, although stopping an SSRI increases the risk of suicidality for several days or weeks. This rule therefore also seriously underestimated the harms of SSRIs. Figure 18.1 FDA meta-analysis of 372 placebo-controlled trials of SSRIs and similar drugs involving nearly 100 000 patients. Odds ratios for suicidal behaviour for active drug relative to placebo by age Other data show that the huge FDA analysis cannot be reliable. An internal Lilly memo from 1984 reported that the German drug agency described two suicides and 16 suicide attempts among only 1427 patients on fluoxetine in clinical trials even though patients at risk of suicide were excluded from the trials. 30 A memo from Lilly Germany listed nine suicides in 6993 patients on fluoxetine in the trials. 31 In contrast, there were only five suicides in total in FDA’s analysis of 52 960 patients on SSRI drugs, or one per 10 000 patients, although one would have expected 74 and 68, respectively, based on the two Lilly reports, or 13 per 10 000 patients. Many suicides are missing in the FDA analysis. In a 1995 meta-analysis, there were five suicides on paroxetine in 2963 patients, 32 which is 17 per 10 000 patients. This meta-analysis wrongly reported two suicides on placebo, which had occurred in the washout period. The UK drug regulator was much more careful than the FDA and did not only search for suicide terms in the documents but also read text in case report forms and narratives. 33 They showed that paroxetine was harmful in adults with major depressive disorder. There were 11 suicide attempts on paroxetine (3455 patients) and only one on placebo (1978 patients), P = 0.058 for the difference. I wonder why no suicides were reported, as we would have expected six on paroxetine. A 2005 meta-analysis that built on data in a report the UK drug regulator had made found nine suicides in 23 804 patients, 34 or four per 10 000. This was an unusually low rate, and it has been shown that the companies underreported the suicide risk. 35 There were other oddities; the researchers found that non-fatal self-harm and suicidality were seriously underreported compared to the reported suicides. A 2005 meta-analysis of published trials including 87 650 patients conducted by independent researchers included all ages and found double as many suicide attempts on drug than on placebo. 36 Even so, they found that many suicide attempts must have been missing, e.g. by asking the investigators, some of whom responded that there were suicide attempts they had not reported, while others replied that they didn’t even look for them in their trials. There were other issues related to trial design that likely led to underestimation of suicide attempts, e.g. events occurring shortly after active treatment is stopped might very well be caused by the drug but were not counted. It is abundantly clear that suicides, suicidality and violence caused by SSRIs are grossly underestimated, 37 and we also know the reasons. First, there is outright fraud. Second, many suicidal events have been coded as something else. Third, the drug industry has taken great care to bias its trials by only recruiting people at very low risk of committing suicide. Fourth, the companies have urged the investigators to use benzodiazepines in addition to the trial drugs, which blunt some of the violent reactions that would otherwise have occurred. Fifth, some trials have run-in periods on active drug, and patients who don’t tolerate it aren’t randomised, which comes close to scientific misconduct, as it artificially minimises the occurrence of suicidality. Sixth, and perhaps the worst of all the biases, events occurring shortly after active treatment is stopped, e.g. because the patients feel very badly, might very well be suicidal events caused by the drug but are often not registered. Seventh, many trials are buried in company archives and these are not the most positive ones. Given what I have just described above, and earlier, e.g. that middle-aged women who use duloxetine for urinary incontinence have a suicide attempt rate that is more than double the rate among other women of a similar age, my take on all this is: SSRIs likely increase the risk of suicide at all ages. These drugs are immensely harmful. Lundbeck’s evergreening of citalopram Lundbeck launched citalopram (Cipramil or Celexa) in 1989. It became one of the most widely used SSRIs and provided the company with most of its income. That was a risky situation to be in but Lundbeck was lucky. Citalopram is a stereoisomer and consists of two halves, which are mirror images of each other, but only one of them is active. Lundbeck patented the active half before the old patent ran out and called the rejuvenated me-again drug escitalopram (Cipralex or Lexapro), which it launched in 2002. When the patent for citalopram expired, generics of Cipramil entered the market at much lower prices, but the price of Cipralex continued to be very high. When I checked the Danish prices in 2009, Cipralex cost 19 times as much for a daily dose as Cipramil. This enormous price difference should have deterred the doctors from using Cipralex, but it didn’t. The sales of Cipralex were six times higher in monetary terms than the sales of citalopram both at hospitals and in primary care. I calculated that if all patients had received the cheapest citalopram instead of Cipralex or other SSRIs, Danish taxpayers could have saved around €30 million a year, or 87% of the total amount spent on SSRIs. How is it possible for doctors to have such a blatant disregard for the public purse to which we all contribute and why can it continue year after year? The old recipe with a blend of money and hyped research seems infallible. A psychiatrist described vividly that when Lundbeck launched Cipralex in 2002, most of the Danish psychiatrists (she did say most, although there are more than a thousand psychiatrists in Denmark) were invited to a meeting in Paris. That meeting seems to have been enjoyable, ‘with expensive lecturers – of course from Lundbeck’s own “stable” – luxurious hotel and gourmet food. A so-called whore trip. Under influence? No, of course not, a doctor doesn’t get influenced, right?’ 38 When the patent of Cipramil was expiring, Jack M Gorman published an article in a special supplement of CNS Spectrums, a neuropsychiatric journal he edits. 39 The article concluded that escitalopram may have a faster onset of action and greater overall effect than citalopram’ 40 Gorman was a paid consultant to Forest that marketed both drugs in North America, and Forest paid Medworks Media, the publisher of CNS Spectrums, to print the article. At the same time, Medical Letter, an independent drug bulletin with no advertising, also reviewed the two drugs and found no difference between them. 41 On one of the occasions where I was invited to give a lecture for Danish psychiatrists, I expressed my doubts that a drug could be better than itself to a person sitting close to me at the lunch table. She was a chemist working at Lundbeck and didn’t agree. She sent me a copy of Gorman’s paper, which on page 2 says: ‘Brought to you by an unrestricted educational grant from Forest Pharmaceuticals, Inc.’ Oh no, I thought I would never accept ‘an unrestricted educational grant’ from a drug company, not even in the form of a reprint, but here it was. All three authors worked for Forest, Gorman as a consultant and the others in the company. The paper was a meta-analysis of three trials that compared the two drugs with placebo. What am I supposed to make out of a paper published in a bought supplement to a journal edited by a person who is also bought by the company? Nothing, I would say. We cannot trust the drug industry, and a paper published this way is nothing but an advertisement. There are so many ways a trial can be manipulated, and in SSRI trials it’s particularly crucial how the statistician deals with dropped out patients and other missing values. 42 On top of this, Lundbeck was in a pretty desperate situation. I therefore wouldn’t believe anything unless I got access to the raw data and analysed them myself. But it isn’t necessary to go to such lengths. What Forest published was small differences between the two drugs and between active drugs and placebo (see Figure 18.2). After 8 weeks, the difference between the two drugs was 1, on a scale that goes from 0 to 60, and the difference between active drugs and placebo was 3. Obviously, a difference of 1 on a 60-point scale has no importance for the patients. Furthermore, as explained in Chapter 4, it doesn’t take much unblinding before we find a difference of 3 between active drugs and placebo, even if the drugs have no effect on depression. There is therefore no good reason to use a drug that is 19 times more expensive than itself. Figure 18.2 Change from baseline in MADRS score throughout 8 weeks; the scale goes from 0 to 60. Redrawn The official task of the government-funded Danish Institute for Rational Drug Therapy is to inform Danish doctors about drugs in an evidence-based fashion. In 2002, the institute reviewed the clinical documentation for Lundbeck’s me-again drug, escitalopram, and informed Danish doctors that it didn’t have clear advantages over the old drug, which contained the same active substance. 43 Lundbeck complained loudly about this in the press and said it was beyond the institute’s competence to give statements that could affect the international competition and damage Danish drug exports. 44 Although it wasn’t beyond the institute’s competence to give recommendations about new drugs, whatever the consequences for drug exports, the institute was reprimanded by the minister of health and it declined to comment when asked by a journalist, for pretty obvious reasons. The Danish drug industry has tried for years to get political backing for closing down the institute, which is a thorn in its flesh, as it reduces sales of expensive drugs, but it hasn’t succeeded. It seems that our highly praised governmental institute is only allowed to tell the truth about imported drugs, not about drugs we export. An untenable position that shows that principles are only valid as long as they don’t cost too much. Two years after these events, the institute announced that escitalopram was better than citalopram and might be tried if the effect of citalopram hadn’t been satisfactory. 45 The institute must have stepped on its toes to find a politically correct way to express themselves. 46 Its information to doctors now stated that they should usually choose the cheapest SSRI, as there are no major differences between the drugs. About escitalopram it said that ‘Two studies have shown that the effect of escitalopram comes somewhat faster than that of venlafaxine and citalopram, but with about the same maximum effect’, and ‘In a single study it was made likely in a subgroup analysis that escitalopram is a little better in severe depression than venlafaxine and citalopram.’ I had a big laugh when I saw the four references in support of these statements. Paper is grateful, as we say; it doesn’t protest, no matter what you write on it. One of the academic authors was Stuart Montgomery, who concealed that he worked for Pfizer helping the company to get sertraline approved at the same time as he worked for the UK drug regulator that approved the drug (see Chapter 10). I laughed again when an employee from the institute was interviewed in the TV news. She was pressured by the journalist who asked her if she couldn’t imagine any situation where it might be an advantage that the drug worked faster. Yes, she said, if a patient was about to throw herself out the window! She learned the hard way how to deal with journalists. Jokes won’t do on the news, particularly not if they are about patients. It was doubly ironic, as it has never been demonstrated that SSRIs decrease the risk of suicide; they seem to increase the risk (see above). Four independent reviews of the evidence – by the FDA, the American advisory group Micromedex, the Stockholm Medical Council and the Danish institute – concluded that escitalopram offers no significant benefit over its predecessor. 47 The Cochrane review on escitalopram says that it’s better than citalopram but warns against this finding because of potential sponsorship bias. 48 The trials were performed by Lundbeck and many negative antidepressant trials never get published. Furthermore, the reporting of the outcomes in the included studies was often unclear or incomplete. Analyses made by disinterested parties who have access to the data, such as scientists working at drug agencies, have repeatedly found that there are no important differences in benefits and harms of the various SSRIs, whereas what gets published is seriously misleading. 29,42,49 Comprehensive reviews by other researchers have also failed to find important differences. 50 In 2003, Lundbeck breached the UK industry code of practice in its advertising. 51 The company breached the code on five counts, notably by claiming that ‘Cipralex is significantly more effective than Cipramil in treating depression’. The company also attributed adverse effects to citalopram in its literature on escitalopram that weren’t mentioned in promotional material for citalopram. This confirms the adage that it’s surprising how quickly a good drug becomes a bad drug when a more expensive drug comes around. The UK advertising campaign was intensive and highly successful, as escitalopram rapidly gained market share. Lundbeck’s CEO, Erik Sprunk-Jansen, retired in 2003 and started a company selling herbal medicine. One of the products is Masculine, which ‘Spices up your love life’, and is said to give extra energy that strengthens the lust and blood circulation, 52 typical mumbo-jumbo pep talk for alternative medicine. It doesn’t seem to matter much what drug pushers sell, as long as they sell something. In 2011, we asked Lundbeck for unpublished trials of its antidepressant drugs, which we needed for our research on suicidality, but we were told that the company, as a matter of principle, doesn’t hand out the clinical documentation that forms the basis for marketing authorisation. The same year, Lundbeck’s new CEO, Ulf Wiinberg, denied in an interview that the increase in suicidal events with happy pills in children and adolescents means that the drugs increase the risk of suicide. 53 He even stated that treatment of depression in children and adolescents decreases the suicide risk, in violation of the labelling that warns that the drugs may increase the risk of suicide. Why does any doctor trust what the companies tell them? Events in America were also interesting. In 2001, Lundbeck’s American partner Forest had performed a trial of citalopram (Celexa) for compulsive shopping disorder (I’m not joking), and Good Morning America told the viewers that this new disorder could affect as many as 20 million Americans of which 90% were women. 54 Gorman appeared as an expert in the programme and said that 80% of the compulsive shoppers had slowed their purchases on Celexa. The ensuing flurry of publicity forced the APA to say it had no intention of adding such a disorder to the DSM. In 2010, the US Justice Department announced that Forest had pleaded guilty to charges relating to obstruction of justice and the illegal promotion of citalopram (Celexa) and escitalopram (Lexapro) for use in treating children and adolescents with depression. 55 Forest agreed to pay more than $313 million to resolve criminal and civil liability arising from these matters and also faced numerous court cases from parents to children who had either committed suicide or had tried. 56 There were also charges that the company launched seeding studies, which were marketing efforts to promote the drugs’ use. Two whistle-blowers would receive approximately $14 million, and Forest signed a Corporate Integrity Agreement. 55,57 Six years earlier, a Forest executive had testified before Congress that Forest followed the law and had not promoted Celexa and Lexapro to children, although Forest had illegally done exactly that. 58 The government mentioned that Forest publicised and circulated the positive results of a double-blind, placebo-controlled Forest study in 2004 on the use of Celexa in adolescents while, at the same time, failed to discuss the negative results of a contemporaneous double-blind, placebo-controlled Lundbeck study on the use of Celexa in adolescents, finished in 2002 in Europe but only mentioned in a textbook in Danish in 2003 in a single line of a chart. 59 For 3 years, Forest executives didn’t disclose those results within the company or to outside researchers who published results on Celexa, and the existence of the Lundbeck study first came to public light when the New York Times published an article about it. Only then did Forest acknowledge the study as well as another, earlier trial that also failed to show any benefits of Lexapro as a depression treatment for children. 55,57 Forest’s official excuse for not mentioning the negative trials was that ‘there was no citable public reference for the authors to examine’. 59 But drug makers often announce trials with positive results without waiting for the results to be published, e.g. Forest issued a news release that highlighted the outcome of the positive Celexa trial already in 2001, shortly after the trial’s completion. Forest had 19 000 advisory board members 58 and used illegal kickbacks to induce physicians and others to prescribe Celexa and Lexapro, which allegedly included cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment. On one occasion, Forest paid physicians five hundred dollars to dine at one of the most expensive restaurants in Manhattan and called them consultants – for the evening it seemed, and they didn’t do any consulting. 54 Vermont officials found that Forest’s payments to doctors in 2008 were surpassed only by those of Eli Lilly, Pfizer, Novartis and Merck – companies with annual sales that were five to 10 times larger than Forest’s. 60 What was Lundbeck’s reaction to the crimes? ‘We know Forest is a decent and ethically responsible firm and we are therefore certain that this is an isolated error.’ 56 Perhaps this confidence in Forest’s business ethics was related to the fact that Lexapro sold for $2.3 billion in 2008. 57 At any rate, we do know something about what it means to be ‘a decent and ethically responsible firm’. In 2009, the US Senate released documents it had requested from Forest. 61 They start out by saying that Forest will communicate that Lexapro offers superior efficacy and tolerability over all SSRIs, which is pure fantasy. We are also told that the antidepressant market is the most heavily detailed category in the drug industry and that the sales mirror the promotional effort. Forest will develop ghostwritten articles for ‘thought leaders’, which will ‘allow us to fold Lexapro messages’, and will also use thought leaders at sponsored symposia, which will be published in supplements to medical journals to ‘help disseminate relevant Lexapro data and messages to key target audiences’. The thought leaders, advisors and Lexapro investigators will be kept informed by monthly mailings, and Forest will use the consultant services of thought leaders and advisors to obtain critical feedback and recommendations on ‘educational and promotional strategies and tactics’. Forest recruited about 2000 psychiatrists and primary care physicians whom the company trained to ‘serve as faculty for the Lexapro Speakers’ Bureau Program’. It was obligatory that speakers used the slide kit prepared by Forest. The documents include details of a huge programme of phase IV studies (seeding trials it seems) and describe that investigator grants would cover the costs of ‘Thought Leader Initiated Phase IV studies with Lexapro’. The outcome of all these studies seemed to have been determined beforehand, even before the studies started, as key messages were listed for each study: Escitalopram has the lowest potential for drug interactions Escitalopram has an excellent dosing profile Escitalopram represents a new more selective and/or potent generation of SSRIs Escitalopram is an effective first-line treatment for depression Escitalopram has a favourable side-effect profile Escitalopram has improved side-effect, drug interaction and safety profiles resulting from the removal of the inactive moiety, the R-enantiomer Escitalopram is a refinement of citalopram in terms of antidepressant effect and tolerability. Forest provided ‘unrestricted grants’ to professional societies, e.g. the American Psychiatric Association, so that they could develop ‘reasonable practice’ guidelines. What was meant by this was ‘to improve the percent of patients who adhere to the full duration of therapy’. Forest became a corporate sponsor of the American College of Physicians ‘which provides additional marketing opportunities’, and this organisation was also involved with developing the ‘reasonable practice’ guidelines. I could throw up. Total corruption of academic medicine resulting in immense harms to patients who cannot get off the drug once they have adhered to ‘the full duration of therapy’. So this is a ‘decent and ethically responsible firm’, 56 right? Antipsychotic drugs Antipsychotics are dangerous drugs that should only be used if there is a compelling reason, and preferably as short-term therapy at a low dose because the drugs produce severe and permanent brain damage. As explained above, even most patients with schizophrenia can avoid the drugs and it results in much better long-term outcomes than if they are treated and substantial financial savings as well. 21 Antipsychotics increase the risk of dying substantially through a variety of mechanisms, which include suicide, cardiac arrhythmias, diabetes and major weight gains. 9 The drug companies have caused tremendous harm by their widespread illegal and aggressive promotion of the drugs for off-label use (see Chapter 3). The legal use is also increasing, e.g. in children, the use of antipsychotics went up eight-fold between 1993– 1998 and 2005–2009, and it doubled in adults. 62 The story of antipsychotics has many similarities to that of the SSRIs. The clinical research wasn’t aimed at clarifying the role of the new drugs for clinicians and patients but was driven by marketing strategy, and new drugs were much hyped although large, independent government-funded trials found they weren’t better than old drugs 63,64,65 (see also Chapter 9). A trial of 498 patients with a first-episode schizophrenia found no difference in discontinuation rates between four newer drugs and haloperidol. 65 Discontinuation rate is a sound outcome, as it combines perceptions of benefits and harms of the drugs. The study was funded by three drug companies but they were kept at arm’s length. Antipsychotics are standard treatment for bipolar disorder, which is mainly iatrogenic, caused by SSRIs and ADHD drugs, and they are also used for depression when treatment with an antidepressant is not enough. We now see advertisements, e.g. for AstraZeneca, about combination therapy for depression, and there are even preparations that combine the drugs in the same pill, e.g. Symbyax from Lilly, which contains Prozac (fluoxetine) and Zyprexa (olanzapine), 48 two of the worst psychotropic drugs ever invented. Like for the SSRIs, there are many perverse trials supporting antipsychotics for virtually everything. In 2011, an AstraZeneca trial studying whether quetiapine could prevent the development of psychosis in people as young as 15 years ‘at risk’ of psychosis was stopped after protests that it was unethical. 66 There is no good reason to believe that these drugs can prevent psychosis, in fact, they cause psychosis in the long run (see above); 21 and most people ‘at risk’ would never have developed psychosis. A 2009 meta-analysis of 150 trials with 21 533 patients showed that psychiatrists had been duped for 20 years. 63,67 The drug industry invented catchy but entirely misleading terms such as ‘second generation antipsychotics’ and ‘atypical antipsychotics’, but there is nothing special about the new drugs, and as they are widely heterogeneous, it’s wrong to divide them into two classes. It’s remarkable that it was possible to show in a meta-analysis of published trials that new drugs aren’t better than old ones, as the research literature is so flawed. Haloperidol is the comparator in most of the trials, and their design is often flawed, using too high doses or too quick dose increases for haloperidol and other old drugs, resulting in a false claim that a new drug is similarly effective but better tolerated. 68 An analysis of 2000 trials in schizophrenia revealed a disaster area of poor-quality research that didn’t even improve over time, and with 640 different instruments to measure the outcome; 369 of these mostly homemade scales were only used once! 69 Unsurprisingly, an internal Pfizer memorandum shows that the flaws are introduced deliberately: 70 If we were going to have to increase dothiepin dosage from 75 mg to 100 mg, we should do so at 1 week rather than at 2 weeks, which would result in a high drop-out rate on dothiepin due to side effects. By 2 weeks, patients have learnt to live with side effects. Zyprexa, another terrible Eli Lilly drug turned into a blockbuster The deceptions worked, as always. Everybody wants a ‘modern’ drug, whatever that means, and this bad habit is extremely costly, even when the ‘modern’ drug is only an old drug in disguise. Olanzapine was an old substance and the patent was running out, but Lilly got a new patent by showing that it produced less elevation of cholesterol in dogs than a never-marketed drug! 9 This was totally ludicrous, and in fact, olanzapine raises cholesterol more than most other drugs. It could therefore have been marketed as a cholesterol-raising drug, but that wouldn’t have made Zyprexa a blockbuster with sales of around $5 billion per year for more than a decade. 9 A Cochrane review from 2005 reported that the largest trial with olanzapine had been published 142 times in papers and conference abstracts. 71 I am not kidding, it was the same trial in 142 publications. The carpet bombing also included criminal activities (see Chapter 3), and the aggressive marketing made Zyprexa the most widely used antipsychotic drug in the world, although it isn’t any better than far cheaper alternatives. In 2005, Zyprexa was Lilly’s top-selling drug at $4.2 billion. 72 Money, marketing and lies ensured that doctors didn’t use the old cheap drugs. In 2002, the sales of Zyprexa were 54 times larger than the sales for haloperidol in Denmark, amounting to a staggering €30 million a year, although our country is very small. There was no excuse for this. Two years earlier, a meta-analysis was published in the BMJ that concluded that ‘the new drugs have no unequivocal advantages for first line use’. 73 The last time I checked the price for Zyprexa, it cost seven times as much as haloperidol. It’s irresponsible to waste so much money, and patient organisations contribute to this. They only know what the drug firms have told them, or what the psychiatrists have told them, which is about the same, as the psychiatrists also generally only know what the drug firms have told them. It was therefore not surprising when the chairman of an organisation for psychiatric patients in 2001 called it unethical that Danish psychiatrists in her view were too slow to use the newer antipsychotics such as Zyprexa and Risperdal (risperidone). 74 A researcher explained that many patients on Zyprexa increased their body weight by 15–25 kg during a few months, that there was a risk of diabetes, and that increased cholesterol was commonly seen. He also commented on the adverse effects of Risperdal and said that the likely reason that the chairman wanted these drugs to be used much more was that the adverse effects were little known. Wise words indeed. In Chapter 3, I described that Lilly agreed to pay more than $1.4 billion for illegal marketing for numerous off-label uses including Alzheimer’s, depression and dementia, and Zyprexa was pushed particularly hard in children and the elderly, although the harms of the drug are substantial, inducing heart failure, pneumonia, considerable weight gain and diabetes. 75 In 2006, internal Lilly documents were leaked to the New York Times, which demonstrate the extent to which the company downplayed the risks of its drug. 72,76 Lilly’s chief scientist, Alan Breier, told employees in 1999 that ‘weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule’, but the company didn’t discuss with outsiders that a 1999 study, disclosed in the documents, found that blood sugar levels in the patients increased steadily for 3 years. 76 Lilly instigated legal action against a number of doctors, lawyers, journalists and activists to stop them from publishing the incriminating leaked documents on the internet, and after the injunction, they disappeared. In 2007, Lilly still maintained that ‘numerous studies … have not found that Zyprexa causes diabetes’, even though Zyprexa and similar drugs since 2003 on their label had carried an FDA warning that hyperglycaemia had been reported. Lilly’s own studies showed that 30% of the patients gained at least 10 kg in weight after a year on the drug, and both psychiatrists and endocrinologists said that Zyprexa caused many more patients to become diabetic than other drugs. 76 Zyprexa is likely more harmful than many other antipsychotics. 77 In 2001, Lilly’s bestselling antidepressant Prozac was running out of patent and the company was desperate to somehow fool people into using Zyprexa also for mood disorders and called it a mood-stabiliser rather than an antipsychotic. It doesn’t stabilise the mood, and it was also a challenge that general practitioners were worried about the harms of antipsychotics, but Lilly was determined to ‘change their paradigm’. The internal documents say it all. In psychiatry, it doesn’t really matter which drugs you have, as most drugs can be used more or less for everything, and psychiatrists are easily amenable for manipulation, even in the way they define and name their diseases. Let’s estimate how many people Lilly has killed with Zyprexa. In 2007, it was reported that more than 20 million people had taken Zyprexa. 78 A meta-analysis of the randomised trials of olanzapine and similar drugs given to patients with Alzheimer’s disease or dementia showed that 3.5% died on drug and 2.3% on placebo (P = 0.02). 79 Thus, for every 100 patients treated, there was one additional death on the drug. Elderly patients are often treated with several drugs and are more vulnerable to their harms, which means that the death rate is likely higher than in younger patients. However, the reviewed trials generally ran for only 10–12 weeks, and most patients in real life are treated for years. Further, drugs like Zyprexa are most used in the elderly, and as deaths are often underreported in trials, the true death rate is likely higher than shown in the meta-analysis. One death in a hundred therefore seems a reasonable estimate to use. I therefore estimate that 200 000 of the 20 million patients treated with Zyprexa have been killed because of the drug’s harms. What is particularly saddening is that many of these patients shouldn’t have been treated with Zyprexa. As Zyprexa is not the only drug, the death toll must be much higher than this. AstraZeneca silenced a trial that showed that quetiapine (Seroquel) led to high rates of treatment discontinuations and significant weight increases while the company at the same time presented data at European and US meetings that indicated that the drug helped psychotic patients lose weight. 80 Speakers Slide Kit and at least one journal article stated that quetiapine didn’t increase body weight while internal data showed that 18% of the patients had a weight gain of at least 7%. 77 AstraZeneca propagated other lies. 77 It presented a meta-analysis of four trials showing that quetiapine had better effect than haloperidol, but internal documents released through litigation showed it was exactly the opposite: quetiapine was less effective than haloperidol. The bottom line of psychotropic drugs How come we have allowed drug companies to lie so much, commit habitual crime and kill hundreds of thousands of patients, and yet we do nothing? Why don’t we put those responsible in jail? 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President Xi Jinping, born in 1953, has indicated his intent to rule indefinitely after China’s legislature amended the constitution in March 2018 to scrap term limits for the presidency. This move was also emblematic of the increasing repression under Xi’s rule.The Chinese Communist Party (CCP) also strengthened its power over the government bureaucracy in a major overhaul of central government structure in March. The party oversees a powerful new government body, the National Supervisory Commission, which is empowered to detain incommunicado anyone exercising public authority for up to six months without fair trial procedures in a system called “liuzhi.”In October, Meng Hongwei, then-president of Interpol, the international police organization, and China’s vice minister for Public Security, disappeared upon return to China and was assumed to be held in “liuzhi.” The CCP also subsumed state bodies in charge of religious, ethnic, and overseas Chinese affairs under a party agency, the United Front Work Department.Authorities dramatically stepped up repression and systematic abuses against the 13 million Turkic Muslims, including Uyghurs and ethnic Kazakhs, in China’s northwestern Xinjiang region. Authorities have carried out mass arbitrary detention, torture, and mistreatment of some of them in various detention facilities, and increasingly imposed pervasive controls on daily life. New regulations in Tibet now criminalize even traditional forms of social action, including community mediation by religious figures. In Hong Kong, a region promised “a high degree of autonomy” under the Sino-British Joint Declaration, the Chinese and Hong Kong governments hastened their efforts in 2018 to undermine people’s rights to free speech and political participation.Human rights defenders continue to endure arbitrary detention, imprisonment, and enforced disappearance. The government maintains tight control over the internet, mass media, and academia. Authorities stepped up their persecution of religious communities, including prohibitions on Islam in Xinjiang, suppression of Christians in Henan province, and increasing scrutiny of Hui Muslims in Ningxia.Authorities increasingly deploy mass surveillance systems to tighten control over society. In 2018, the government continued to collect, on a mass scale, biometrics including DNA and voice samples; use such biometrics for automated surveillance purposes; develop a nationwide reward and punishment system known as the “social credit system”; and develop and apply “big data” policing programs aimed at preventing dissent. All of these systems are being deployed without effective privacy protections in law or in practice, and often people are unaware that their data is being gathered, or how it is used or stored.In 2018, animated by the global #MeToo movement, a number of Chinese women stepped forward exposing people who they said had sexually harassed them. Government censorship dampened subsequent public outrage.In one of its only human rights concessions all year, Chinese authorities allowed Liu Xia, an artist and the widow of 2010 Nobel Peace Prize winner Liu Xiaobo, to leave for Germany in July after eight years of legally baseless house arrest. However, the decision of authorities to bar her family members from also leaving reflects Beijing’s campaign to punish dissent and restrict expression globally.China’s growing global power makes it an exporter of human rights violations, including at the United Nations, where in 2018 it sought to block participation of its critics. China again ranked among countries singled out for reprisals against human rights defenders, and in March successfully advanced a Human Rights Council (HRC) resolution on a retrograde approach that it calls “win-win” or “mutually beneficial” cooperation. In this view, states do not pursue accountability for serious human rights violations but engage merely in “dialogue”; moreover, there is no role for independent civil society, only governments, and a narrow role for the UN itself.Few governments spoke forcefully against these developments, even in the face of Chinese government harassment of people in their own countries or pressure on foreign companies to publicly support Chinese government positions.Human Rights DefendersThe case of human rights lawyer Wang Quanzhang is emblematic of authorities’ ruthlessness toward human rights defenders and those activists’ fortitude. Beijing police detained Wang amid a national crackdown on human rights lawyers and activists in August 2015; while detained he was reportedly tortured with electric shocks and forced to take medications. In July, Wang was finally allowed to meet his lawyer for the first time. Charged with “subversion of state power,” he could face life imprisonment if convicted. During Wang’s detention, Li Wenzu, his wife, along with families of other lawyers and activists detained during the crackdown, have campaigned relentlessly for his release despite having to endure incessant intimidation and harassment.Authorities continued politically motivated prosecutions and disbarments of human rights lawyers. In January, police detained lawyer Yu Wensheng, charging him with “inciting subversion of state power” and “obstructing public duties.” Judicial authorities revoked or suspended the licenses of over a dozen human rights lawyers, and even some who retain licenses have been unable to find work due to police pressure on employers.In 2018, the courts handed down lengthy prison terms to a number of prominent human rights activists after protracted and sham prosecutions. In July, a Wuhan court sentenced veteran democracy activist Qin Yongmin to 13 years in prison for “subversion of state power.” Qin, 64, has previously spent a total of 22 years in prison or in “Re-education Through Labor.”Also in July, a Chongqing court sentenced political cartoonist Jiang Yefei to six-and-a-half years in prison for “subversion of state power” and “illegally crossing a national border.” In 2015, Thai authorities forcibly repatriated Jiang and human rights activist Dong Guangping to China even after the pair had been granted UNHCR refugee status. Dong, who was tried alongside Jiang, was given a three-and-a-half-year sentence for inciting subversion and illegal border crossing.Other defenders continue to face long detentions without trials or verdicts. Liu Feiyue, founder of the human rights news website Civil Rights and Livelihood Watch, was detained in November 2016 and charged with “inciting subversion of state power.” He was tried in August 2018 but had not yet been sentenced at time of writing. Veteran activist and founder of the human rights website “64,” Tianwang Huang Qi, has been detained since November 2016 but not yet tried. Huang suffers from several health conditions for which he has not received adequate treatment, including possible imminent kidney failure and lung inflammation.More human rights defenders were detained in 2018. In July, authorities detained Dong Yaoqiong after she poured ink over a poster of President Xi in Shanghai. Police later held her in a psychiatric hospital and prevented her father from seeing her. In August, Guangxi police detained activist and a leader in the Tiananmen Square protests Zhou Yongjun for possessing materials related to Falun Gong, a banned religious group in China. Also in August, Shenzhen police detained dozens of labor and student activists after they gathered to show support to factory workers at the welding machinery company Jasic International, who were fired for trying to form a union. Some were later released but 14 remained in custody or under house arrest at time of writing.Authorities also tried to silence Chinese human rights defenders abroad by harassing and detaining their families in China. In January 2018, Guangzhou authorities forcibly disappeared Li Huaiping, wife of Chen Xiaoping, a US-based journalist for the Chinese-language Mirror Media Group. The disappearance came shortly after Chen interviewed Guo Wengui, a Chinese billionaire fugitive who exposed corruption among China’s ruling elite. Authorities continually harassed the China-based family members of Canadian human rights activist Anastasia Lin, banning them from travel abroad and threatening to persecute them “like in the Cultural Revolution.”In 2018, authorities continue to subject various activists and lawyers to travel bans, surveillance, detention, and torture and ill-treatment for their efforts to engage with the UN. Using human rights treaties for advocacy was cited in the criminal indictment against activist Qin Yongmin, who was sentenced to 13 years in prison.Freedom of ExpressionChinese authorities continue to harass and detain journalists who cover human rights issues, as well as their interviewees. In May, Beijing police physically assaulted and briefly detained a cameraperson for the Hong Kong broadcaster Now TV reporting on a human rights lawyer’s court hearing. In July, Hunan police detained independent blogger Chen Jieren after he wrote articles alleging corruption by provincial party officials; state media repeatedly attacked Chen as an “internet pest” who had “polluted the online space.” In August, Shandong police broke into the home of retired professor Sun Wenguang as he was giving a live interview with the US broadcaster Voice of America (VOA). Sun was subsequently put under house arrest. Police later also briefly detained VOA journalists who attempted to interview Sun again.Authorities expanded their internet censorship regime to suppress politically sensitive information and “vulgar” content. In January 2018, social media platform Weibo suspended several of its most popular programs after authorities ordered it to clean up “wrong-oriented” and “vulgar” information. In April, regulators shut down Neihan Duanzi, a parody and meme app with over 38 million monthly users.In January 2018, Chinese authorities forcibly disappeared Swedish citizen and bookseller Gui Mihai while he was traveling with Swedish diplomats. Gui, a publisher of books about China’s political intrigues, had been imprisoned for two years from 2015 to 2017 after being abducted from Thailand.In August, media reports revealed that Google, which suspended its search service in China in 2010 citing censorship concerns, had been developing a censored search engine app for the Chinese market. The app would reportedly comply with China’s expansive censorship requirements by automatically identifying and filtering sites blocked by the Great Firewall, China’s internet filtering system.The government also tightened its ideological grip over universities. A number of professors, including foreigners, were punished for making comments critical of the government. In July, the University of Nottingham Ningbo China removed Stephen Morgan from its management board after he wrote an online essay critical of the Chinese Communist Party. In August, Guizhou University dismissed economics professor Yang Shaozheng, alleging him of “disseminating politically incorrect views.” Peking University did not renew the contract of American professor Christopher Balding, who had previously launched a campaign calling on Cambridge University Press to resist the Chinese government’s pressure to censor academic articles.The Chinese government also pressured foreign companies to adhere to disputed terms and policies. In January, US-based Marriott International apologized for listing Taiwan and Tibet as separate countries on its website after authorities shut down the website and app in China for a week. In March, Marriott fired an employee for “liking” a pro-Tibet tweet. After Chinese authorities threatened to ban them from operating in China, dozens of international airlines made changes on their websites to refer to Taiwan as part of China.Freedom of ReligionThe government restricts religious practice to five officially recognized religions in officially approved premises. Authorities retain control over religious bodies’ personnel appointments, publications, finances, and seminary applications. The government classifies many religious groups outside its control as “evil cults,” and subjects members to police harassment, torture, arbitrary detention, and imprisonment.In February, revised Regulations on Religious Affairs came into effect. Designed to “curb extremism” and “resist infiltration,” they ban unauthorized teaching about religion and going abroad to take part in training or meetings.In March, a Yunnan court sentenced Christian pastor John Sanqiang Cao to seven years in prison for “organizing others to illegally cross the border” between China and Myanmar. Cao had been involved in educational projects for impoverished minority groups in Myanmar.A crackdown on Christian churches intensified in Henan province during the year, as authorities demolished dozens of church buildings or the crosses atop of them, prevented believers from gathering in house churches, and confiscated bibles and other religious materials.In September, the Vatican and Beijing reached a historic deal, ending a decades-long standoff over authority to appoint bishops in China. China’s estimated 12 million Roman Catholics are divided between an underground community that pledges allegiance to the Pope and a government-run association where bishops are state appointed. Under the accord, Beijing will propose names for future bishops and the Pope will have veto power over the appointments.In August, in the heavily-Hui Muslim Ningxia region, thousands of Huis gathered to protest the demolition of the Grand Mosque in the town of Weizhou. Ningxia authorities have reportedly also moved Islamic icons and Arabic signs from streets across the region.Hong KongBeijing’s assault on Hong Kong’s freedoms, particularly the rights to free expression, association and political participation, worsened considerably in 2018.The Hong Kong government has continued to disqualify pro-democracy figures from running for seats on Hong Kong’s Legislative Council (LegCo). In January and October, the Hong Kong Electoral Affairs Commission disqualified Demosisto Party candidate Agnes Chow and Labor Party candidate Lau Siu-lai, respectively, stating that their promotion of “self-determination” for Hong Kong is “inconsistent” with the Basic Law.The Hong Kong and Chinese governments have harassed people for peaceful pro-independence speech. In March, they denounced pro-democracy scholar Benny Tai, equating his hypothetical discussion of Hong Kong independence with “a threat to national security.” In August, Chinese Ministry of Foreign Affairs officials had requested that the Hong Kong Foreign Correspondents Club cancel a talk by Andy Chan, a pro-independence activist. After the club refused, Hong Kong authorities rejected without explanation its vice-president’s application to renew his work visa.In August, Demosisto reported that police had briefly detained and interrogated two members in the mainland in March and August. In September, a pro-independence group, Studentlocalism, said police in the mainland had harassed relatives of two members for their political activities in Hong Kong.In September, new regulations went into effect allowing mainland law to prevail in Hong Kong’s West Kowloon railway terminus and all operating trains going between Hong Kong and mainland China—a significant step in China’s erosion of Hong Kong’s autonomy.In an unprecedented move, the Hong Kong government in September banned a political party—the pro-independence Hong Kong National Party. Authorities stated that the party “poses a real threat to national security,” against which they had to take “preventive measures.”XinjiangChinese authorities are hostile to many expressions of Uyghur identity, and have in recent years justified sweeping repression as a necessary response to threats of terrorism.The Chinese government began waging a “Strike Hard Campaign against Violent Extremism” in Xinjiang in 2014. But the level of repression increased dramatically after Communist Party Secretary Chen Quanguo was transferred from the Tibet Autonomous Region to assume leadership of Xinjiang in late 2016.Since then, authorities have stepped up mass arbitrary detention, including in pretrial detention centers and prisons, both of which are formal facilities, and in “political education” camps, which have no basis under Chinese law. Credible estimates indicate that 1 million people are being indefinitely held in the camps, where Turkic Muslims are being forced to learn Mandarin Chinese, praise the government and party, and abandon many aspects of their distinct identity. Those who resist or are deemed to have failed to “learn” are punished.Outside these detention facilities, authorities subject Turkic Muslims in Xinjiang to extraordinary restrictions on personal life. Authorities have recalled passports throughout the region, and to travel from one town or another, people have to apply for permission and go through checkpoints. They are subjected to persistent political indoctrination, including compulsory flag-raising ceremonies and political or denunciation meetings. With unprecedented levels of control over religious practices, authorities have effectively outlawed the practice of Islam in the region.They have also subjected people in Xinjiang to pervasive surveillance. Authorities employ high-tech mass surveillance systems that make use of QR codes, biometrics, artificial intelligence, phone spyware, and big data. And they have mobilized over a million officials to monitor people, including through intrusive programs in which officials regularly stay in people’s homes.The campaign has divided families, with some family members in Xinjiang and others abroad caught unexpectedly by the tightening of passport controls and border crossings. Children have at times been trapped in one country without their parents. The government has barred Turkic Muslims from contacting people abroad, and has pressured some Uyghurs and ethnic Kazakhs living outside the country to return to China, while requiring others to provide detailed personal information about their lives abroad.The collective punishment of families was particularly striking in the case of five US-based Radio Free Asia Uyghur Service journalists. Media reports in February said their relatives in Xinjiang have been detained in retaliation for their journalism about the region.In November, China underwent scrutiny of its human rights record through the Human Rights Council’s Universal Periodic Review (UPR). More than a dozen mostly Western countries challenged China’s widespread detention of Turkic Muslims in Xinjiang, with some echoing the high commissioner’s call to allow UN experts access to the “political education” camps. No member country of the Organisation of Islamic Cooperation explicitly addressed the issue, although Turkey expressed concern at the “confinement of individuals without legal grounds” without making specific reference to Xinjiang.TibetAuthorities in Tibetan areas continue to severely restrict religious freedom, speech, movement, and assembly, and fail to redress popular concerns about mining and land grabs by local officials, which often involve intimidation and arbitrary violence by security forces. Authorities intensified surveillance of online and phone communications.There were clear findings by UN human rights experts that the charges were baseless. Nonetheless, courts sentenced former political prisoner Tsegon Gyal in January to three years in prison and language activist Tashi Wangchuk in May to five years.Several hundred Tibetans traveling on Chinese passports to India for a January 2018 teaching by the Dalai Lama were forced to return early when officials in Tibetan areas threatened retaliation against those traveling abroad and their family members back home.Intensified political education has been reported in monasteries and schools, and for the public at large. Tibetan authorities have used a nationwide anti-crime campaign to encourage people to denounce members of their communities on the slightest suspicion of sympathy for the exiled Dalai Lama or opposition to the government.Several more cases were reported in 2018 of land grabs by local officials for construction projects, both in the Tibet Autonomous Region and other Tibetan areas. In Driru county, 30 villagers were detained in May for allegedly sharing with international media information about the arrest of a village leader who had led popular opposition to a mining project on a sacred mountain.Tibetans continue to self-immolate to protest Chinese policies; four more such protests took place between November 2017 and time of writing.Women’s and Girls’ RightsIn 2018, the #MeToo movement gained momentum in China as a slew of prominent academics, journalists, and activists were accused on social media of sexual misconduct. After a prominent state media TV host and a senior Buddhist monk at a government-controlled temple were accused of sexual harassment, censors deleted social media posts about those cases. In June, China University of Petroleum authorities held Ren Liping, a student who had accused an ex-boyfriend of raping her on campus, for six days in a hotel room after she protested against the university and police for mishandling her allegations.While women in China may be more willing to speak out against sexual harassment, seeking legal redress is still very difficult. Chinese law prohibits sexual harassment, but its failure to define the term makes meaningful legal action nearly impossible.Women continue to face widespread discrimination in the job market. In the 2018 national civil service job list, 19 percent specified a requirement or preference for men, up from 13 percent from the previous year. Technology giants including Alibaba and Tencent pledged to ensure gender equality in their recruitment.As China faces an unprecedented sex ratio imbalance and aging population, authorities promoted traditional roles for women, encouraging them to marry early and have children. The “bride shortage” in China has triggered trafficking of women from a number of neighboring countries, an abuse largely ignored by the Chinese government. Although the “one-child policy” has been relaxed to a “two-child policy,” women and girls continue to face violations of their reproductive rights.The Chinese government remains hostile to women’s rights activism. In March, social media platforms Weibo and WeChat permanently suspended the accounts of Feminist Voices, a social media publication run by outspoken feminists.Sexual Orientation and Gender IdentityWhile China decriminalized homosexuality in 1997, it lacks laws protecting people from discrimination on the basis of sexual orientation or gender identity, and same-sex partnership is not legal.In March, the Beijing International Film Festival pulled an award-winning film featuring a homosexual relationship, “Call Me By Your Name,” after it failed to pass government approval. In April, Chinese social media platform Weibo announced that posts related to gay culture would be taken down, as part of a “cleanup” effort. The move prompted widespread protest: many people posted messages with the hashtag “I am gay” and rainbow emoticons. Weibo subsequently dropped the restriction.In Hong Kong, the territory’s highest court in July ruled that the government’s denial of a visa and associated benefits to the same-sex spouse of a legal resident amounted to discrimination. Around the same time, Hong Kong authorities decided to move a selection of 10 children’s books with LGBT themes to the “closed stacks” in public libraries.A gay teacher in September filed a suit against his former school, alleging that he was fired because he posted information on social media about a lesbian, gay, bisexual, and transgender (LGBT)-themed event that he had attended.Refugees and Asylum SeekersChina continued to arrest and forcibly return hundreds, and perhaps thousands, of North Koreans, who Human Rights Watch considers refugees sur place, to North Korean state security services, who has long tortured, sexually abused, and imprisoned them. Beijing refused to consider fleeing North Koreans as refugees and would not grant UNHCR access to them or areas on the North Korea-China border, further violating its obligations as a party to the 1951 Refugee Convention.Key International ActorsWhile some governments and parliaments publicly expressed concerns about Beijing’s human rights violations, and continued to try to observe trials and meet with human rights defenders in China, few took forceful action to end abuses or press for accountability.In March, China proposed a resolution at the Human Rights Council, focusing on its vision for “win-win cooperation” while omitting any role for independent civil society, any mention of accountability, and other core parts of the council’s mandate. The resolution was adopted by a comfortable margin with the US as the only no vote. Throughout the year, members of the US Congress and the administration called for sanctions and export controls.In July, Germany secured the release of Liu Xia. In September, Malaysia’s new premier, Anwar Ibrahim, publicly called for talks with China about violations in Xinjiang. Sweden did not secure the release of bookseller Gui Minhai; Australia adopted new laws to counter Chinese political interference at home, but took few meaningful steps to challenge the root cause of political repression in China. The European Parliament and the European Union’s External Action Service repeatedly called for release of jailed and disappeared human rights lawyers, dissenters, and activists and expressed concerns about the situation in Xinjiang, but their efforts were partly frustrated by the EU leaders’ failure to echo these concerns and calls publicly at a summit in July.UN Secretary-General Antonio Guterres visited China in April and September without publicly expressing his concern about these issues. However, new UN High Commissioner for Human Rights Michelle Bachelet, the Committee to Eliminate Racial Discrimination, and the assistant secretary-general for human rights expressed concern particularly about Xinjiang and abuses of human rights defenders.China continues to use its permanent seat on the UN Security Council to block important discussions of human rights issues. In March 2018, China and Russia successfully mobilized other council members to prevent then-High Commissioner for Human Rights Zeid Ra’ad al-Hussein from addressing the council on Syria. In October 2018, it circulated a letter expressing its opposition to the "internationalization" of efforts to address the Rohingya crisis in Myanmar and its opposition has stymied stronger Security Council action to react to the crisis.Foreign PolicyThroughout the year China pressed ahead with its “One Belt, One Road” initiative despite the lack of safeguards or respect for human rights in many participating countries. Some governments, including Myanmar and Malaysia, backed away from previously agreed bilateral investment arrangements, citing unsustainable debt and concerns about sovereignty.China also pressed other governments, including Egypt, Kazakhstan, and Malaysia, to forcibly return asylum seekers to China.Major Chinese technology companies, including Huawei, iFlytek, and ZTE, all of which enjoy close relations with the government and contribute to the police’s mass surveillance efforts, tried to expand abroad in 2018. Some were rebuffed by Australia, Canada, and the US due to security concerns.