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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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I've read all the commentary in this thread to date and offer the following observations. I identify no particular individuals here except those in the public sphere. Other individuals don't need me to tell them who they are or what they should believe.In my opinion Carl Bernstein has become a political hack, and his comments are mere opinions and fodder for the haters in our midst. It is interesting and telling that the vast majority of the comments in this thread are nothing more than extremely vitriolic, disparaging remarks based on ad hominem attacks on personality and style over policy and results, and, except for a few remarks posted with salient, cogent, objective and reasonable commentary, there is not one word in the others about policy, not even in critique, or accomplishments, or anything other than disparaging, denigrating, demonizing attacks and lamentations about personal characteristics and past activities that bear little if any relevance to present challenges. It's one big echo chamber of groupthink vitriol, animus and outright hatred, much like what is spewed daily on MSNBC and CNN, reported negatively and spun subliminally by the alphabet TV networks and print media, and air-headed commentary by self-anointed experts on talk shows, late night so-called comedy shows and by Hollywood elitists.If believing that displaying disdain for any individual because of his or her persona, or style, or mannerisms, or any other characteristic is more valid or important than considering substantive achievements and results, so be it. I care not a fig about the former only the latter. Let those who do that do it. It says more about them than what they say about those whom they denigrate.If anyone would care to consider that there is another side of these issues, the information below is available so that maybe it will provide a different perspective or at least elicit statements to support which of it may justify those disparaging remarks and vacuous personal attacks:To begin, consider the linked article below, a relevant and legitimate comparison between Obama's and Trump's economic impacts and the current state of the Trump economy, notwithstanding the recent stock market gyrations. It's far more cogent than all of Obama's unprecedented, protocol-averse disparagement of his predecessor, even on foreign soil, and his self-aggrandizing bloviating remarks during his speaking engagements that are designed and intended solely to enhance his own precious legacy:Obama’s last 21 months to Trump’s first 21Obama wants credit for faster growth, but compare Obama’s last 21 months to Trump’s first 21. By Andy Puzder, Nov. 25, 2018Federal Reserve Chairman Jerome Powell said last month that the U.S. is experiencing “a remarkably positive set of economic circumstances.” The superb numbers speak for themselves, but who gets the credit?For eight years under President Obama, the growing burden of government suppressed the economic recovery that should have followed the recession of 2008-09. Mr. Obama nonetheless has claimed responsibility for today’s boom, asking Americans in September to “remember when this recovery started.” Yet it wasn’t until President Trump took office that the economy surged. His administration’s pro-business policies—cutting taxes, slashing regulations and encouraging energy production—released the pent-up dynamism of American capitalism. The result is a rising tide that is lifting boats across every class and region of the country.The last recession officially ended in June 2009. During a typical recovery, the economy grows at a rate between 3% and 4%, and the Obama administration predicted such a surge in its 2010 midsession review. It never came. The “recovery” of those years often felt much like a recession. In the post recession period under Mr. Obama, gross domestic product grew an average of 2.2%.GDP growth staggered along at 1.5% in Mr. Obama’s final six full quarters in office. In contrast, growth doubled to 3% during Mr. Trump’s first six full quarters. And through three quarters of 2018, the economy has grown at a 3.3% clip and is on track to hit at least 3% for the full calendar year. That would make this year the first with 3% growth since 2005.To get an even clearer picture, compare the contiguous periods of the Trump and Obama years. Accelerating growth is having an impact on the job market. By August of this year, Mr. Trump’s pro-business policies had driven job openings to their highest level since 2000, when the Bureau of Labor Statistics started tracking the number. With business optimism on a two year streak of record highs, the increase in job openings over Mr. Trump’s first 21 months has averaged an impressive 75,000 a month. Over Mr. Obama’s last 21 months in office, the number of job openings increased an average of 900 a month. That’s less than 1/80th of Mr. Trump’s average.Even more impressively, the current surge in job openings has occurred while a record number of people are already employed. During Mr. Obama’s last 21 months, the number of employed Americans increased an average of 157,000 a month. Under Mr. Trump, the increase has accelerated to 214,000 a month, a 36% improvement. The number of employed people in October hit 157 million—the highest ever.This increase in job openings and people employed has created increased demand for workers. In March the number of job openings exceeded the number of people the BLS considers unemployed for the first time since the bureau began reporting the data. There have been more openings than job seekers every month since. By September, there were one million more job openings than unemployed people.Today’s jobs also offer more hours than in the recent past. In Mr. Obama’s last 21 months the economy added an average of 148,000 full-time workers a month. Under Mr. Trump that number has risen to 218,000, a 47% improvement.The combination of more full-time workers with higher wages and more overtime opportunities has pushed up weekly earnings. In Mr. Obama’s final 21 months, weekly earnings rose an average of $1.31 a month. Under Mr. Trump, weekly earnings have increased an average of $1.84 cents a month: a 40% improvement that’s come mostly since tax reform took effect in January. Over that period, weekly earnings have grown an average of $2.31 a month, a 76% increase over Mr. Obama’s last 21 months. Maybe those tax cuts weren’t Armageddon after all.A broad cross section of the country has benefited from the strengthening economy. The unemployment rate declined 13% during Mr. Obama’s last 21 months, but from there it has dropped another 23% during Mr. Trump’s tenure. Today unemployment rests at 3.7%, near a 50-year low. Since the government began reporting the data, unemployment has never been as low as it is today for African-Americans, Latinos, Asians and people with only a high-school education. The rate for women is at a 65-year low, and for teenagers, a 50-year low.Despite Mr. Obama’s attempts to take credit, this is a Trump economic boom. Unleashed by Mr. Trump’s policies and powered by the initiative of American workers, the U.S. economy is creating prosperity for every class and color of people. Sorry, Mr. Obama, but you didn’t build that.Opinion | Trump Kicked the Sluggish Economy Into High GearSome Pertinent Accomplishments of the Present Administration:Recently renegotiated the NAFTA treaty that was severely disadvantageous to the U.S. and replaced it with the more equitable USMCA (United States Mexico Canada Agreement) that will more equitably benefit the U.S. as well as the other two parties.ECONOMY: 4.8 million new jobs were created. 250,000 jobs were added in October; record number of Americans employed, Hispanic and African American unemployment at record lows with 3.7% unemployment rate, lowest since 1969, and over 150 million employed, the largest in history; 3.1% wage increases, a 9 yr. high. There are presently about a million jobs open and available, more jobs than people on food stamps, and more people are out of poverty then ever in history. Since the loss of over 200,000 manufacturing jobs during the Obama Administration that told us “manufacturing was dead in the US,” nearly 450,000 have been added thus far in this administration, in construction, transportation and energy for domestic consumption and export. Overall, $11.7 trillion in new wealth has been created.Rolling Back Job Killing Regulations:President Trump signed an Executive Order, mandating that two regulations must be eliminated for every regulation created in order to reduce compliance costs.The Administration actually eliminated 22 regulations for every new regulatory action.The Administration issued 67 deregulatory actions while only imposing three new regulatory actions.In FY 2017, the Administration saved $8.1 billion in lifetime net regulatory cost savings, equivalent to $570 million per year.Throughout 2017, President Trump has made good on his promise to cut red tape, and in doing so has reenergized the United States’ agricultural, energy, and infrastructure sectors by freeing them from oppressive and stifling regulations.President Trump has signed 15 Congressional Review Act resolutions into law, more than any other president, ending burdensome Obama-era rules and regulations.According to a study by NERA Economic Consulting, implementing the Obama Administration’s plan under the Paris Climate Agreement could have cost the United States economy nearly $3 trillion and 6.5 million industrial sector jobs by 2040.President Trump signed 15 Congressional Review Act resolutions into law that is estimated to save American taxpayers $3.7 billion.According to a study by NERA Economic Consulting, if we implemented the Obama Administration’s plan under the Paris Climate Agreement, it could have cost the U.S. economy more than $3 trillion annually and 6.5 million industrial sector jobs by 2040.President Trump signed an Executive Order that reduced the time it took to approve infrastructure projects from 10 years to two years.Rolled back President Obama’s job killing power plan and ended the previous administration’s war on coal.UNPRECEDENTED REGULATORY ROLLBACK:To date, 860 regulatory actions have been withdrawn or removed from active status. The WSJ said President Trump is "rolling back more regulations than any President in history."RECORD-SETTING NUMBER OF CONGRESSIONAL REVIEW ACT (CRA) BILLS SIGNED:President Trump has signed a record-breaking 15 CRA bills to roll back regulations.Since the CRA became law in 1996, only one had ever been signed (George W. Bush in 2001)Along with Executive Orders, these bills will reduce regulatory costs by $18 billion annually.Immigration: Enforced immigration laws to protect American communities and American jobs.Called on Congress to fully fund a wall along the Southern border, to close legal loopholes that enable illegal immigration, to end chain migration, and to eliminate the visa lottery program.Pulled the United States out of negotiations for a “Global Compact on Migration,” a plan for global governance of immigration and refugee policy that may have compromised U.S. sovereignty. (Like we don’t have enough problems without our immigration policies being dictated by foreign “global” governance.)Department of Homeland Security took action to wind down the unconstitutional Deferred Action for Childhood Arrivals (DACA) program in an orderly fashion, following the assessment of the Department of Justice (DOJ) that DACA lacks legal authorization. This action gives Congress the opportunity to consider appropriate legislative solutions, as required by our Constitution.The Administration rescinded the unconstitutional Deferred Action for Parents of Americans (DAPA) program.The Department of Homeland Security launched the office of Victims of Immigration Crime Engagement. (VOICE)From President Trump’s inauguration through the end of FY 2017, U.S. Immigration and Customs Enforcement (ICE) made 110,568 arrests of illegal aliens, a 40 percent increase compared to the same time period the prior year. Over the same time period, removals that resulted from arrests increased by 37 percent. Of the illegal aliens arrested by ICE, over 92 percent had criminal convictions or pending criminal charges, were ICE fugitives, or were illegal reentrants.In FY 2017, there was a 17 percent decrease in border removals, which shows the deterrent effect of strong interior enforcement.The number of counties participating in the 287(g) program, which gives state and local law enforcement entities delegated authority by ICE to enforce immigration in their jurisdiction, has doubled.In FY 2017, ICE conducted 226,119 removals. The proportion of removals resulting from ICE arrests increased from 65,332, or 27 percent of total removals in FY 2016 to 81,603, or 36 percent of total removals, in FY 2017.The Trump Administration cracked down on sanctuary cities by improving the Administration of Federal grants to increase information sharing on illegal aliens.SAFEGUARDING AMERICA’S COMMUNITIES:The Department of Justice announced more than $98 million in grant funding to hire 802 additional full-time law enforcement officers.President Trump signed an Executive Order to restore state and local law enforcement’s access to surplus Defense Department equipment through the 1033 program, including safety equipment.The DOJ has worked with Central American partners to arrest and charge about 4,000 MS-13 members. This includes the alleged leader of MS-13’s “East Coast Program.”The Department of Homeland Security arrested 796 MS-13 gang members and associates in FY 2017, an 83 percent increase from the previous year.President Trump signed three Executive Orders aimed at cracking down on international criminal organizations. In June, Attorney General Jeff Sessions announced the creation of the new National Public Safety Partnership, a cooperative initiative with cities to reduce violent crime.Ended ‘Catch and Release’ Immigration Policy, and Department of Justice transferred additional Immigration Judges to six detention centers near the border to work in courts with excessive backlog.LAW ENFORCEMENT and JUSTICE:Department of Justice announced more than $98 million in grant funding through the office of Community Oriented Policing Services COPS Hiring Program to allow 802 additional full-time law enforcement officers.President Trump signed Executive Order 13809 to restore State and local law enforcement’s access to surplus equipment from the Defense Department, such as armored vehicles.In June 2017, Attorney General Jeff Sessions announced the creation of the new National Public Safety Partnership, a cooperative initiative with cities to reduce violent crimes.Attorney General Sessions expanded Project Safe Neighborhoods to encourage U.S. Attorney’s to work with communities to develop customized crime reduction strategies.Attorney General Sessions returned to longstanding Department of Justice charging policy for our Federal prosecutors, trusting them once again and directing them to return to charging the most serious, readily provable offense.Prosecutors were directed by the Department of Justice to focus on taking illegal guns off our streets. Criminals charged with unlawful possession of a firearm has increased 23 percent.August 2018 - More Than 20 Individuals Associated With MS-13 Were Arrested In California On Federal And State Charges In Connection With Gang Activities.Additionally, two federal indictments were unsealed: one charging two MS-13 members with kidnapping and murder in aid of racketeering and another charging three MS-13 gang members with conspiracy and assault with a dangerous weapon in aid of racketeering.PROTECTING THE RIGHTS OF ALL AMERICANS:Department of Justice has supported students whose free-speech rights have been under attack on university campuses.Department of Justice’s Civil Rights Division is reviewing a complaint by a coalition of more than 60 Asian-American associations that alleges racial discrimination against Asian-Americans in Harvard University’s admissions policies and practices.The Department of Justice secured a guilty plea for the first case prosecuted under the Hate Crimes Prevention Act involving a victim targeted because of gender identity.CONFRONTING ORGANIZED CRIME:President Trump and the Department of Justice have aggressively confronted organized crime from street gangs to criminal cartels.President Trump signed three Executive Orders – 13773, 13774, and 13776 – aimed at cracking down on international criminal organizations, including drug cartels and gangs, and preventing violence against law enforcement officers.Attorney General Sessions designated MS-13 as a priority for the Organized Crime Drug Enforcement Task Force, to allow Federal law enforcement to utilize an expanded toolkit in its efforts to dismantle the organization.The United States, El Salvador, Guatemala, and Honduras joined together to charge more than 4,000 MS-13 and 18th Street gang members in the United States and Central America, including the alleged leader of MS-13’s “East Coast Program.”Department of Justice convicted eight members of an international criminal organization, known as the Rendon-Reyes Trafficking Organization, on Federal charges arising from their scheme to force young women and girls from Mexico and Latin America into prostitution.Signed Rep. Rutherford's STOP School Violence Act and Sens. Cornyn-Murphy "Fix NICS Act." $2 billion for school safety.NATIONAL SECURITY AND DEFENSE:Rebuilding The Military. President Trump is rebuilding our military, defeating terrorist organizations, and confronting rogue nations to protect America and our allies.Upon taking office, President Trump directed the rebuilding of the United States Military, a new national defense strategy, a comprehensive nuclear posture review, and fielding state-of-the-art ballistic missile defenses.President Trump has worked with Congress to increase defense spending, reverse the defense sequester, expand our military capacity, and modernize its capabilities.The President has empowered the Secretary of Defense and our military commanders to make decisions, seize the initiative, and win – without micromanagement from Washington.President Trump revived the National Space Council to develop and implement a new national space policy and strategy.President Trump elevated the U.S. Cyber Command into a major warfighting command, to advance U.S. efforts in cyberspacePresident Trump withdrew from the U.N. Global Compact on Migration to reassert American sovereignty over our borders.President Trump signed Executive Order 13780, which restricted travel from certain countries that do not have sufficient security or share enough information.President Trump and his Administration worked tirelessly to defeat ISIS and terrorism around the world.ISIS lost its last town after U.S.-led forces retook Raqqa.President Trump directed the State Department to send aid through USAID directly to Christians and other minorities facing genocide in the Middle East.During his first international trip, President Trump pushed for a coalition of nations to confront Iran and attended the opening of the Global Center for Combating Extremist Ideology. It was created to empower Muslim-majority countries in fighting radicalization.President Trump announced a new strategy for Afghanistan to protect the American people based on stability and security so terrorists cannot use the country as a base to threaten U.S. interests.The new strategy put pressure on the Taliban, and set conditions for a peaceful settlement between the Afghanistan government and the Taliban.The President warned Pakistan that no partnership can survive a country’s tolerance for militants and terrorists and they must take action.The partnership with India is vital, and they make important contributions to Afghanistan’s safety, security, and development.President Trump is putting maximum pressure on North Korea to denuclearize.President Trump and North Korean leader Kim Jong Un agreed to meet on June 12th in Singapore.Secretary of State Mike Pompeo and other representatives of the United States government traveled to Pyongyang, North Korea on May 9 to prepare for the President’s upcoming meeting with North Korean leader Kim Jong Un. During Secretary Pompeo’s visit, the North Korean leadership released three American detainees. President Trump appreciates leader Kim Jong Un’s action to release these American citizens, and views this as a positive gesture of goodwill. The three Americans appear to be in good condition and were all able to walk on the plane without assistance. All Americans look forward to welcoming them home and to seeing them reunited with their loved ones.The Treasury Department implemented sanctions on 57 North Korean individuals and entities as part of the Maximum Pressure Campaign.Under President Trump’s leadership, the United Nations Security Council unanimously passed new sanctions on North Korea for their continued aggressive behavior.The President signed an Executive Order sanctioning parties that engaged in trade or financing with North Korea.The Treasury Department placed a sanction on the Chinese Bank of Dandong for “illicit North Korean financial activity.”President Trump announced a new Afghanistan strategy that strengthens our support for Afghan security forces, delegates authority to military leaders, and demonstrates our resolve to defeat terrorism.NATO allies and partners increased troop contribution to NATO’s Resolute Support Mission in Afghanistan.President Trump is confronting Iran’s aggression.President Trump in consultation with his national security team has approved a new strategy for Iran.Not certifying they are in full compliance with the Joint Comprehensive Plan of Action, known as the Iran Deal,Focusing on neutralizing the Government of Iran’s destabilizing influence and constraining its aggression, particularly its support for terrorism and militants,Revitalizing our traditional alliances and regional partnerships as bulwarks against Iranian subversion and restore a more stable balance of power in the region,Deny the Iranian regime – and especially the Islamic Revolutionary Guard Corps (IRGC) – funding for its malign activities, and oppose IRGC activities that extort the wealth of the Iranian people,Counter threats to the United States and our allies from ballistic missiles and other asymmetric weapons,Rally the international community to condemn the IRGC’s gross violations of human rights and its unjust detention of American citizens and other foreigners on specious charges, andDeny the Iranian regime all paths to a nuclear weapon.Department of the Treasury sanctioned 25 entities and individuals involved in Iran’s ballistic missile program in order to further monitor and prevent any acts of terrorism.The first week of January, 2018, the Treasury Department sanctioned additional Iranian entities tied to Iran’s ballistic missile program and Iran’s Revolutionary Guard Corp.The Department of Treasury put in place new sanctions against Iranian companies in response to Iran’s provocative launch of a space vehicle.President Trump ordered missile strikes against a Syrian airbase after the Assad regime used it to launch chemical weapons attacks against civilians.President Trump prevented further chemical weapons attacks by announcing detection of their preparation and warning Syria that they would be struck again if the attacks were carried out.President Trump imposed new sanctions on the Maduro dictatorship in Venezuela, targeting the regime itself, and not just individuals, for the first time.The new financial sanctions prohibit dealings in new Venezuelan debt and its corrupt oil company. The regime will no longer be able finance its debt using U.S. banks.NEW ACTIONS AGAINST RUSSIA:President Donald J. Trump announced additional measures to punish those who seek to undermine American democracy and security.The Trump Administration will continue to take a direct approach to confront Russia where it threatens our institutions, our interests, or our allies.The Trump Administration imposed sanctions against 16 Russian entities and individuals that were previously indicted for their roles in Russian interference in the 2016 presidential election.Additionally, the Trump Administration imposed sanctions against two Russian intelligence agencies and six senior Russian intelligence officials for their significant efforts to undermine U.S. cyber security.Two of the officials are newly sanctioned. The remaining two agencies and four individuals were previously sanctioned and are being re-designated under the Countering America’s Adversaries Through Sanctions Act (CAATSA).The Trump Administration called out the Russian government for its malicious cyber activity targeting U.S. critical infrastructure, including failed attempts on the energy sector.This action follows the Trump Administration’s January 29, 2018 Report on Senior Foreign Political Figures and Oligarchs in the Russian Federation.Finally, the Trump Administration released a separate DHS/FBI Joint Analytic Report that shares technical threat information to improve the network defenses of American infrastructure and raises the cost on the Russian government.POWERFUL SANCTIONS:President Trump has already taken action to counter the challenge from Russia and has previously imposed numerous rounds of sanctions.On February 13, the Trump Administration proposed a new rule under the Patriot Act that would prohibit Latvia’s ABLV bank, which has been laundering illicit Russian funds, from opening or maintaining correspondent accounts in the United States.On December 20 and 21, the Trump Administration announced Russia Magnitsky Sanctions and Global Magnitsky Sanctions respectively.On December 20, the Trump Administration imposed export controls against two Russian companies that were helping Russia to develop missiles that violate the INF Treaty.In response to Russia’s occupation of Crime and aggression in Eastern Ukraine, the Trump Administration sanctioned 58 targets on June 20, 2017, and 42 targets on January 26, 2018.CONFRONTING RUSSIAN INTERFERENCE:Since the start of his term, President Trump has taken consistent action to call out and stop Russian efforts to undermine the United States.On February 16, 2018, the Trump Administration attributed the worldwide NotPetya cyber-attack to the Russian military.On September 13, 2017, the Trump Administration banned the use of Kaspersky Labs software on U.S. government computers due to Kaspersky ties to Russian intelligence.On March 15, 2017, the Trump Administration charged three Russians, including two officers of the Russian Federal Security Service (FSB), with criminal charges for the 2014 Yahoo hack.The Trump Administration has maintained the closure of two Russian compounds and the expulsion of 35 diplomats in response to Russian interference in the 2016 election.In 2017, the Trump Administration established the Election Infrastructure Government and Sector Coordinating Councils to increase coordination and information sharing across all levels of government and with the private sector providers of voting and registration systems.During the 2017 elections, the Trump Administration provided onsite cybersecurity support to States, which have the responsibility to ensure that their electoral infrastructure is secure, and will continue to provide this assistance in 2018.COUNTERING RUSSIAN AGGRESSION:The President is shoring up America's allies and standing up to Russia’s malign influence across the globe.The Trump Administration released a new National Security Strategy that makes clear that Russia is undertaking actions that threaten the security of the United States and our allies, and outlines steps to stop Russia’s malign interference.The Trump Administration has increased funding for the European Deterrence Initiative, providing billions to increase U.S. troop readiness in Europe, deter Russian aggression, and help defend our NATO allies.The Trump Administration has enhanced its support for Ukraine’s Armed Forces to help Ukraine improve its ability to defend itself.The Trump Administration is working to pressure Russia back into compliance with the INF Treaty to ensure that Russia does not gain strategic advantage from its treaty violations.On August 31, 2017, the Trump Administration announced the closure of a Russian consulate and two diplomatic annexes in response to Russia’s cutting of the number of U.S. diplomatic personnel in Russia.FULLY FUNDING AND REBUILDING THE U.S. MILITARY:Signed $700 billion in DoD funding to rebuild our military in 2018, the largest amount in history. Gave the military a 2.4% pay raise, the biggest since 2010. Secured an extra $21 billion to rebuild our military in 2017.August 2018 - President Trump signed the FY2019 National Defense Authorization Act, allocating a historic $716 billion dollars for defense spending including a 2.6 percent pay raise for our service men and women and an increase of 15,600 troops across the Army, Navy, Air Force, and Marine Corps.FULFILLING OUR COMMITMENT TO OUR COUNTRY’S VETERANS:President Trump is making sure the government fulfills its commitment to our country’s Veterans.President Trump signed the Veterans Accountability and Whistleblower Protection Act to allow senior officials in the Department of Veterans Affairs (V.A.) to fire failing employees and establish safeguards to protect whistleblowers.This resulted in Veterans Affairs firing 1,298 employees, suspending 425, and demoting 73.After it passed unanimously in August 2017, President Trump signed the Veterans Appeals Improvement and Modernization Act.This streamlined the lengthy process that veterans undergo when appealing disability benefits claims with the Veterans Affairs.The President signed the Harry W. Colmery Veterans Educational Assistance Act, an important step in providing our nation’s heroes the support they have earned.This funded the post-9/11 GI Bill, which provided educational benefits to veterans, service members, and their family members, including tuition, fees, books, housing, and additional costs.The President signed the V.A. Choice and Quality Employment Act of 2017 to authorize $2.1 billion in additional funds for the Veterans Choice Program (VCP).President Trump signed a bill to allow the V.A. to fire incompetent employees.President Trump signed legislation to fully fund the popular V.A. Choice Program.The Trump Administration created a new White House V.A. Hotline, staffed by veterans and family members.Veterans Affairs increased transparency and accountability by launching an online “Access and Quality Tool.” This provides veterans a way to access wait time and quality of care data.President Trump and Veterans Affairs Secretary Dr. David Shulkin announced three initiatives to expand access to healthcare for veterans using telehealth technology:“Anywhere to Anywhere Veterans Affairs Health Care” allows Veterans Affairs providers to use telehealth technology to serve veterans no matter where the provider or veteran is located.V.A. Video Connect allows veterans and providers to connect by video across the country.The Veteran Appointment Request (VAR) application allows veterans to schedule appointments at Veterans Affairs facilities on digital devices.DEFEATING ISIS:Signed a Presidential Memorandum directing the Secretary of Defense to develop a plan to defeat ISIS.In six months, nearly a third of all territory was reclaimed from ISIS in Iraq and Syria.Iraqi forces have recaptured Mosul from ISIS, a decisive blow that moves us one step closer towards fulfilling President Trump's commitment to their ultimate defeat.In Iraq, ISIS lost its last town when U.S.-led coalition forces retook Raqqa.FOREIGN POLICY - OPPOSING TRADE PRACTICES THAT UNDERMINE NATIONAL SECURITY:President Trump addressed global overcapacity and unfair trade practices in the steel and aluminum industries by announcing a 25 percent tariff on steel imports and 10 percent tariff on aluminum imports.Took action to protect America’s critical steel and aluminum industries, which were harmed by unfair trade practices and global excess capacity.The president exercised his authority to impose a 25 percent global tariff on steel imports and a 10 percent global tariff on aluminum imports in order to protect our national security.The tariffs on steel and aluminum are anticipated to reduce imports to levels needed for domestic industries to achieve long-term viability.As a result, these industries will be able to re-open closed mills, sustain a skilled workforce, and maintain or increase production.The strengthening of our domestic steel and aluminum industries reduces our reliance on foreign producers.PROMOTING FAIR AND RECIPROCAL TRADE:President Trump put America first in trade so American workers aren’t put at a disadvantage.One of President Trump’s first actions was to withdraw the United States from the Trans-Pacific Partnership, advancing his agenda to protect American workers.The Trump Administration began renegotiations of trade agreements that contribute to the U.S. trade deficit and harmed American workers.Renegotiations of the North American Free Trade Agreement are still underway to modernize the deal so that all countries benefit.President Trump worked to bring foreign investment back to the United States so more goods are made in America by American workers.South Korean companies announced 64 projects that will invest more than $17 billion in the U.S. over four years and will purchase $58 billion in goods and services.Foxconn announced its investment of $10 billion in Wisconsin to build a factory that will employ thousands of workers directly, and up to 22,000 workers indirectly.Toyota and Mazda announced a $1.6 billion investment that will go toward a new manufacturing plant in the U.S., creating an estimated 4,000 jobs.At the White House, Broadcom Limited announced they were moving their headquarters back to the United States, bringing potentially $20 billion in annual revenue.President Trump worked to promote the sale of more American products abroad.President Trump and King Salman of Saudi Arabia oversaw the signing of a historic $400 billion in deals between U.S. and Saudi companies.The Trump Administration made enforcement of U.S. trade laws a top priority and has already made significant progress.To defend U.S. national security interests, President Trump blocked a foreign company from acquiring a U.S. business for only the fourth time in history.Since President Trump was sworn into office, the Department of Commerce has initiated 79 antidumping and countervailing duties (AD/CVD) investigations.The U.S. Trade Representative (USTR) self-initiated a Section 301 investigation into whether Chinese policies, acts, and practices related to technology transfer, licensing, and intellectual property are unreasonable or discriminatory. This is the first use of Section 301 since 2001.President Trump delivered on his promise to roll back the Obama Administration’s bad deal with Cuba, which benefitted the Cuban regime at the expense of the Cuban people.The Treasury Department and State Department put new sanction rules to channel economic activity away from the Cuban government, particularly the military, and towards the people of Cuba.PRESERVING AMERICAN COMPETITIVENESS:President Trump took action to address Chinese policies and practices that are harming American innovation.The president directed his administration to consider a range of actions to respond to China’s acts, policies, and practices involving the unfair and harmful acquisition of U.S. technology.The Trump Administration proposed adding 25 percent additional tariffs on certain products that are supported by China’s unfair industrial policy.Sectors subject to the proposed tariffs will include aerospace, information communication technology, and machinery.The U.S. Trade Representative (USTR) confronted China’s discriminatory technology licensing practices through a World Trade Organization (WTO) dispute proceeding.INVESTIGATING THREATS TO AMERICAN INNOVATIONIn August, the Trump Administration launched an investigation under Section 301 of the Trade Act of 1974 into Chinese acts, policies, and practices related to technology transfer, intellectual property, and innovation.This was the first Section 301 investigation since 2013.The U.S. Trade Representative (USTR) confronted China's discriminatory technology licensing practices through a World Trade Organization (WTO) dispute proceeding.USTR led an extensive investigation based on a thorough analysis of evidence and comments received from academics, think tanks, law firms, trade associations, and American companies and workers.The investigation concluded that China forces U.S. companies seeking to license technologies to Chinese entities to do so on non-market based terms.China imposes contractual restrictions on the licensing of intellectual property and foreign technology into their country, but does not put the same restrictions on contracts between two Chinese enterprises.The investigation concluded that China directs and unfairly facilitates investments and acquisitions to generate large-scale technology transfers from U.S. companies to Chinese entities.A Chinese government-backed fund helped Apex Technologies Co., a Chinese investment consortium, acquire a U.S. computer-printer maker which had previously sued Apex over patent infringement.The investigation concluded that China conducts and supports cyber intrusions into U.S. companies to access their sensitive commercial information, such as trade secrets.In 2014, the U.S charged five Chinese military hackers for cyber-esponiage committed against U.S. corporations and a labor organization for commercial advantage.An interagency analysis estimated that China's unfair acts, policies, and practices caused tens of billions in dollars in damages to the United States each year.CONFRONTING UNFAIR TRADE:President Trump has made clear that his Administration will confront unfair trade practices that harm American commerce.Since taking office, President Trump has sought to confront unfair trade practices that have harmed American commerce for far too long.The President’s Administration conducted 82 antidumping and countervailing duty investigations in 2017.This was a 58 percent increase in investigations over 2016.In January, the President announced new safeguard tariffs on imported large residential washing machines and solar cells.The Trump Administration successfully litigated WTO disputes targeting unfair trade practices and protected our right to enact fair trade laws.In February 2018, USTR won a WTO compliance challenge against China’s unfair antidumping and countervailing duties on U.S. poultry exports, and China announced the termination of those duties.In November 2017, the United States won a WTO dispute regarding Indonesia’s unfair import licensing regime restricting U.S. agricultural exports.In October 2017, a WTO compliance panel found that U.S. tuna labeling rules designed to inform consumers about safe fishing practices were consistent with WTO standards.In September 2017, the WTO rejected allegations by the European Union that Boeing was receiving prohibited subsidies.In June 2017, a WTO compliance panel rejected almost all claims by the European Union that alleged U.S. subsidies to Boeing were causing serious prejudice to Airbus, instead finding that 28 of 29 challenged programs were consistent with WTO rules.BUILDING CONFIDENCE AND RESPECT FOR AMERICA:President Trump has used an America First foreign policy to restore respect for the United States throughout the world and to advance our interests.After President Trump’s personal intervention, three student athletes from the University of California, Los Angeles, were released from China.An American, a Canadian, and their three children were released from Taliban custody after United States Government and Pakistani forces secured their release.The Trump Administration secured Otto Warmbier’s release from North Korea.Sandy Phan-Gill was released from Chinese detention after President Trump and his Administration intervened.Aya Hijazi was released from an Egyptian prison and welcomed to the White House by President Trump.Secretary of State Mike Pompeo and other representatives of the United States government traveled to Pyongyang, North Korea on May 9 to prepare for the President’s upcoming meeting with North Korean leader Kim Jong Un. During Secretary Pompeo’s visit, the North Korean leadership released three American detainees. The Americans were welcomed home by President Trump and Melania.President Trump followed through on his promise and recognized Jerusalem as the capital of the State of Israel, and directed the relocation of the U.S. Embassy. After announcing the United States' recognition of Jerusalem as the capital of Israel, President Trump quickly and efficiently opened the Embassy in Israel at a low cost to tax payers.The State Department announced the new US Embassy in Israel would move to Jerusalem. The Trump Administration withdrew from UNESCO to show it would not stand for the anti-Israel bias of the organization.On May 14, 2018, the United States officially opened our Embassy in Jerusalem, Israel, 70 years to the day that President Truman recognized Israel as an independent country, making the United States the first nation to do so.After meeting with North Korea’s Vice Chairman Kim Yong Chol in the Oval Office, President Donald J. Trump said that the North Korean summit, planned for June 12 in Singapore was back on. He called Friday’s meeting with Kim Yong Chol a “great start,” and confirmed the Vice Chairman gave him a letter from Chairman Kim Jong Un. Regarding the negotiations, the President said, “We’re going to deal.” Yesterday, Secretary of State Mike Pompeo said President Trump has been very clear he wants the complete denuclearization of the North Korean peninsula, and expects both leaders to enter the summit in Singapore “with their eyes wide open and with clear understanding of the possibilities of the future.”RESTORING AMERICAN INFLUENCE ABROAD:President Trump has made historic trips and delivered speeches abroad restoring America’s influence around the world.President Trump went on a historic 12-day tour through Asia, including visits to five countries and attended three regional summits to promote America’s interests.South Korea and Japan pledged to build closer defense collaboration with the United States, and the President underscored the commitment of the United States to providing advanced military equipment.Cooperation was boosted between the Quad countries (the United States, Japan, India and Australia) on the sidelines of ASEAN in Manila.President Trump reaffirmed the commitment of the United States to promote prosperity and security in the region by modernizing America’s development finance institutions and increasing their coordination with Japanese counterparts.President Trump traveled to the Middle East and Europe to solidify relations with our allies in both regions and to push for greater commitments and cooperation.President Trump visited Mecca, Jerusalem, and Rome, three of the world’s holiest places.In Saudi Arabia, President Trump pushed for a coalition of nations to confront Iran and attended the opening of the Global Center for Combating Extremist Ideology.President Trump persuaded allies to develop national plans to boost defense spending up to 2 percent of GDP by 2024, and for NATO to formally join the coalition to defeat ISIS at the 2017 NATO Leaders’ meeting.President Trump visited Poland and a meeting of the G-20, where he pushed for closer cooperation and American First policies.With G20 partners and the World Bank, the U.S. championed the establishment of the Women Entrepreneurs Finance Initiative (WeFi), which could leverage in excess of $1 billion in financing to support women entrepreneurs.NORTH KOREA: UN Security Council unanimously passed new sanctions on North Korea.President Trump secured new commitments from Vietnam and China to increase pressure.China affirmed it would fully implement UN Security Council resolutions to pressure North Korea.As a result, North Korea has not launched a test missile in nearly a year as negotiations continue for full denuclearization of the peninsula.KEEPING OUR PROMISE ON U.S.-CUBA POLICY:The President kept his promise to roll back the Obama Administration's bad deal on Cuba that benefitted the Cuban regime at the expense of the Cuban people.August 2018 - The Trump Administration announced the creation of the Iran Action Group in a further demonstration of its commitment to pressure the Iranian Regime to change its hostile and destabilizing behavior.HEALTHCARE: The Department of Agriculture provided more than $1 billion in fiscal year 2017 to be used to improve access to health care services for 2.5 million people in rural communities.President Trump mobilized his entire Administration to address drug addiction and opioid abuse by directing the declaration of a Nationwide Public Health Emergency.President Trump created a bipartisan opioid commission and they issued 56 recommendations to help defeat the opioid crisis.In October 2017, President Trump directed The Department of Health And Human Services to declare the opioid crisis a public health emergency, allowing grant money to be used to combat abuse.President Trump signed the International Narcotics Trafficking Emergency Response By Detecting Incoming Contraband With Technology (INTERDICT Act) that would give customs agents $9 million for screening tools on the border.President Trump appropriated more money to the cause. In April 2017, HHS announced it would provide $485 million in grants to states and territories to combat the opioid crisis. In fiscal year 2017, HHS invested nearly $900 million in opioid-specific funding.Proposed changes to Medicaid to combat the opioid crisis.President Trump signed an Executive order to reform the United States healthcare system to take the first steps to expand choices and alternatives to Obamacare plans and increase competition to bring down costs for consumers.Contrary to disingenuous opposition assertions, these proposals will not eliminate coverage for pre-existing conditions.The Secretary of Labor agreed to expand access to Association Health Plans (AHPs), which could potentially allow American employers to form groups across State lines.The Executive Order directed the Departments of the Treasury, Labor, and Health and Human Services to implement the changes.President Trump concluded there is no appropriations for cost-sharing reduction (CSR) payments to insurance companies under Obamacare.CSR payments have no authority and are unlawful.The bailout of insurance companies through these unlawful payments is yet another example of how the previous administration abused taxpayer dollars and skirted the law to prop up a broken system.President Trump repealed Obamacare’s individual mandate, which required individuals to purchase a health care plan they may not want or be able to afford.IMPROVING ACCESS TO AFFORDABLE, QUALITY HEALTHCARE:President Trump repealed the individual mandate, which forced people to buy expensive insurance that they may not want or did not need. The mandate disproportionately hurt the poor: 80% of those affected made less than $50,000.Expanded access to Association Health Plans (AHPs) allowing small business to pool risk across states.Enacted $31 billion in Obamacare tax relief.President Trump signed a six-year extension of CHIP to fund healthcare for 9 million children.Under President Trump, The FDA has approved the most number of generic drugs in history in order to increase competition in the marketplace and lower the cost of prescription drugs for all Americans.Efforts are being realized on the side of the consumer as prices have gone down and drug competition has gone up.Under President Trump, Americans have access to more affordable healthcare with the ruling from the Department of Treasury that allows for Short-Term Limited Duration plans to be extended up to 12 months.August 2018 - HHS awarded $125 million in grants to 1,352 community health centers across all U.S. States, Territories, and the District of Columbia. These community health centers provide affordable, accessible, cost-effective and quality primary healthcare to young patients, rural residents and lower-income Americans nationwide.August 2018 - The FDA Helped To Facilitate Trade Between The U.S. and Foreign Trading Partners. In order to complete this the FDA announced a new export certification program for certain FDA-regulated food products and the fees it will assess for issuing new export certifications.September 2018 - The Department Of Health And Human Services awarded $60 million to support community health centers impacted by huricanes Harvey, Irma, and Maria. Funding came from the Bipartisan Budget Act by President Trump in February.September 2018 - The FDA Announced Their Global Efforts To Increase Transparency With Drug Manufacturers WorldwideThe FDA has committed to add more transparency and will continue to prioritize inspections of manufacturers to ensure a product's quality.IMPROVING THE LIVES OF RURAL AMERICANSIn December 2017, the U.S. Department of Agriculture signaled that that they planned to give states more flexibility in how they administer food stamps.The Department of Agriculture issued guidance that would give more flexibility to state operations of the Supplemental Nutrition Assistance Program (SNAP).The new program maximized flexibility and holds states more accountable for the delivery of food benefits.President Trump created the Interagency Task Force on Agriculture and Rural Prosperity that Secretary Sonny Perdue chairs and developed suggestions.Suggestions include focusing on broadband access, improving the lives of rural Americans, developing methods to support a rural workforce, harness technological innovation for rural communities, and focusing on economic development in rural areas.August 2018 - USDA Announced An Investment Of More Than $124 Million To Help Rebuild And Improve Rural Water Infrastructure In 23 StatesSeptember 2018 - The USDA Announced That They Would Partner With HHS To Support Rural Communities Combating Opioid Misuse.Under this partnership, cooperative extension partners will be able to apply for grants fromHHS to help communities combat Opioid Use DisordersSeptember 2018 - The USDA Announced That They Formalized An Agreement With A Nonprofit Organization To Purchase Homes From The USDA And Convert Them Into Transitional Housing For People Recovering From Opioid MisuseThese houses will allow houses in Kentucky's Hart and Rockcastle counties to be converted into transitional housing for individuals and families. This is the first initiative that will allow the department to sell vacant and foreclosed homes at a discounted price to provide housing, treatment, and job training for people in drug treatment and recovery.ESTABLISHING AMERICAN ENERGY DOMINANCE:For the first time in 70 years, the United States is energy independent.President Trump is reversing years of policies that locked-up American energy and restricted our ability to sell to other countries.The Department of the Interior proposed its largest oil and gas lease of over 76 million acres in the Gulf of Mexico.President Trump signed an Executive Order to expand offshore oil and gas drilling and open more leases to develop offshore drilling.President Trump and his Administration acted aggressively to increase exports of energy resources to the global market.This allowed financing for coal and fossil energy projects.The Department of Energy announced the approval of the Lake Charles Liquefied Natural Gas terminal.American LNG export opportunities increased under the Trump Administration.Oil and gas development was unleashed because of expanded resources and infrastructure needed to get them to market.The Administration approved the Keystone XL and Dakota Access pipelines, supporting an estimated total of 42,000 indirect jobs and $2 billion in wages.The Administration announced the approval of the New Burgos Pipeline, a cross-border project that will export U.S. gasoline to Mexico.The Department of the Interior promoted responsible oil and gas development on Federal lands.President Trump directed the Environmental Protection Agency (EPA) to rescind the Obama Administration’s Clean Power Plan (CPP).According to NERA Economic Consulting, the CPP would have increased electricity rates by as much as 14 percent, costing American households up to $79 billion.The EPA reconsidered Obama-era rule on methane emissions that would cost American energy developers an estimated $530 million annually.REPEALING THE CLEAN POWER PLAN:Following the principles established by the President’s Executive Order on Energy Independence, EPA has proposed the repeal of the “Clean Power Plan.”The EPA was directed by the Energy Independence Executive Order to repeal of the Clean Power Plan.The Administration estimates that repealing the Clean Power Plan could eliminate up to $33 billion in compliance costs in 2030.The proposed repeal of the Clean Power Plan respects the limits of the EPA’s authority.The Clean Power Plan was originally issued under an expansive and legally dubious view of the EPA’s authority under Section 111 of the Clean Air Act.The Plan authorized EPA to dictate the content of the Nation’s energy portfolio, a power well outside its authority under the Clean Air Act.It also severely restricted States’ long-held authority to make choices about energy production and use within their borders.STREAMLINING SUPERFUND CLEANUPS:EPA Administrator Pruitt launched a task force to provide recommendations on how to streamline and improve the Superfund program, which is responsible for cleaning up land contaminated by hazardous waste.In May 2017, EPA Administrator Pruitt announced the creation of a Superfund task force to look at ways to streamline and improve the Superfund program.The Superfund task force released 42 detailed recommendations with the following goals in mind:Expediting cleanup and remediationRe-invigorating responsible party cleanup and reuseEncouraging private investmentPromoting redevelopment and community revitalizationEngaging partners and stakeholdersRE-LAUNCHING THE SMART SECTORS PROGRAM:EPA has re-launched launched the Smart Sectors Program to partner with the private sector to achieve better environmental outcomes.The lead for each sector serves as the ombudsmen within the respective agency across program offices, conducts educational site tours, analyzes data and advises options for environmental improvement, and develops reports that profile the impact of each sector. It also works to streamline EPA practices and operations.EXPANDING AMERICAN ENGERGY:Signed legislation to open the Arctic National Wildlife Refuge to domestic energy production.Approved the Keystone XL and Dakota Access pipelines, with 42,000 jobs and $2 billion in earnings.Repealed the Clean Power Plan, a regulation estimated to increase energy costs by billions.Kept campaign promise to get America out of the Paris Climate Agreement.BUILDING STRONGER RURAL COMMUNITIES:President Donald J. Trump’s Infrastructure Initiative will help ensure Americans living in rural communities have access to the quality infrastructure they deserve.The President’s infrastructure plan will establish a Rural Infrastructure Program to invest in rebuilding and modernizing rural infrastructure. The Rural Infrastructure Program will seek to:Use outcomes-driven planning efforts and capital improvements to rebuild and modernize rural infrastructure.Grow business revenues and personal incomes in rural areas by expanding access to markets, customers, and employment opportunities.Enhance regional connectivity for rural communities through interregional and interstate projects developed by the public and private sectors.Spur economic growth and competitiveness by closing infrastructure gaps to attract more development and manufacturing investments in rural America.President Trump and his Administration allocated $50 billion to empower rural America to address the infrastructure needs of their communities. The $50 billion dedicated to rural America represented 25 percent of all Federal funds in the President’s plan.80 percent of the Rural Infrastructure Program funds will go directly to the governor of each State as determined by a formula.20 percent of the Rural Infrastructure Program funds will be provided to selected States that apply for Rural Performance Grants.FUNDING FLEXIBILITY:The President’s plan will give states the flexibility to address the unique needs of their rural communities.States will be provided funding without burdensome bureaucratic commands on how they should spend it.The federal funding provided by the President’s plan will not be awarded in pre-packaged, asset-specific amounts, as is often the case with Federal programs.Funds provided under the President’s proposal will go directly to the governor’s office of the State receiving funds.This will allow Governors to make investments based on the individual infrastructure needs of their rural communities.CREATING BROAD ELIGIBILITY:President Trump’s plan will make a broad range of infrastructure assets eligible for funding under his Rural Infrastructure Program.President Trump’s infrastructure plan will enable the rebuilding and modernization of rural infrastructure across a broad range of asset classes.The array of broad asset classes eligible for funding under President Trump’s plan will include:Transportation projects which will rebuild roads, bridges, railways, and other vital infrastructure.Broadband deployment projects which will improve access for rural communities.Water and waste projects to help ensure rural families have access to clean water.Power and electric projects to provide rural areas with reliable, affordable power.Water resources projects to better manage flood risk and improve rural water supplies and waterways.In July 2018, Department of Transportation introduced a new pilot program that will boost military recruitment and help with the nationwide shortage of commercial vehicle drivers by allowing 18 – 20 year olds who possess a U.S. Military equivalent of a commercial driver’s license (CDL) to operate large trucks in interstate commerce.EXPANDING BROADBAND ACCESS FOR RURAL AMERICANS:President Trump understands how important expanding broadband access is to ensuring a better quality of life and increasing economic opportunity for rural Americans.President Trump has made clear that broadband should be an infrastructure priority.The President’s plan will provide States with the flexibility to invest in the needs of their rural communities, including broadband.The Rural Infrastructure Program allowed governors to spend 100 percent of Federal funds they received on broadband access.President Trump signed an Executive Order in January on “Streamlining and Expediting Requests to Locate Broadband Facilities in Rural America.”This was built upon the efforts of the Rural Infrastructure Program by the Trump Administration.SOCIAL PROGRAMS, INCLUDING FIGHTING BACK AGAINST OPIOIDS:President Trump and his Administration are fighting back against drug addiction and opioid abuse.President Trump declared a Nationwide Public Health Emergency to address the opioid crisis.The President’s Council of Economic Advisers (CEA) found evidence that suggests that drug overdoses involving opioids were underreported by as much as 24 percent.The Administration provided nearly $500 million to states to prevent and treat opioid abuse. Another $500 million was requested in the 2018 FY Budget.In April, the Department of Health and Human Services (HHS) issued a comprehensive 5-point strategy to combat the opioid abuse crisis.The Department of Justice announced that fentanyl substances are a drug class under the Controlled Substances Act. This meant anyone who possesses, imports, distributes or manufactures illicit fentanyl-related substances would be subject to criminal prosecution similar to other controlled substances. Anyone who possesses, imports, distributes, or manufactures any illicit fentanyl-related substance will be subject to criminal prosecution similar to other controlled substances.The DOJ announced its first-ever indictments against two Chinese nationals and their North American-based associates for distributing large quantities of fentanyl and other opiate substances.In an opioid fraud crackdown, the DOJ charged more than 400 people, including doctors and medical facilities, for prescribing unnecessary opioids, fueling the drug crisis.In 2017, the Administration provided nearly $500 million to States to prevent and treat opioid abuse. The President’s FY 2018 Budget requests another $500 million.On National Drug Take Back Day, the Drug Enforcement Administration collected a record-breaking 912,305 pounds – 456 tons – of potentially dangerous expired, unused, or unwanted prescription drugs at more than 5,300 collection sites. This was a record-breaking day, with collections from more than 5,300 sites.PROTECTING LIFE:President Trump recognizes the precious gift of life and protects the sanctity of life at all stages. In his first week in office, President Trump reinstated and expanded the Mexico City Policy that prevented $9 billion in foreign aid from being used to fund the abortion industry.President Trump de-funded a U.N. agency for colluding with China’s brutal program of forced abortion and sterilization.President Trump worked with the Congress to sign a bill overturning an Obama midnight regulation that prohibited States from defunding abortion service providers.The Trump Administration published guidance which promises to enforce the Obamacare requirement that taxpayer dollars should not support abortion coverage in exchange plans.Reinstated the Mexico City Policy to ban any U.S. foreign aid to organizations that perform abortions.Signed a Congressional Review Act bill to allow states to restrict Planned Parenthood Funding.EXPANDING SCHOOL CHOICEPresident Donald J. Trump and his Administration have supported expanding school choice across the country so every parents have a voice in their children’s education.In President Trump’s FY 2018 budget request, school choice was a priority for increased funding, including supporting $1 billion in Furthering Options of Children to Unlock Success grants for public school choice and $250 million to promote private school choice through the Education Innovation and Research Program.The Department of Education has overseen the first year of the Every Student Succeeds Act (ESSA) to empower States with the flexibility they need to educate their students.35 States and the District of Columbia have had their ESSA plans approved and the Department of Education is reviewing the plans for the remaining states.The Department of Education is urging states to embrace the opportunity provided by ESSA to end top-down mandates from Washington, D.C.Secretary DeVos conducted a ReThink School tour in 13 schools across 6 states to showcase schools that were finding innovative solutions to better serve students.REFORMING STUDENT AIDPresident Trump and his Administration are taking steps to reform the student aid process.Secretary DeVos implemented the year-round distribution of Pell grants, instead of limiting these grants to the Spring and Fall semesters.Low-income students will now have access to these funds over Summer and Winter breaks so they can earn their degrees faster with fewer loans.The Department of Education reformed the student loan servicing process to improve the customer experience and lower costs.The Free Application for Federal Student Aid is being reformed to be more accessible to students.Experts from the financial services industry were brought into the Department of Education to modernize the way FSA offers and services student loans.ENDING HARMFUL REGULATIONS:President Trump and his Administration have identified and begun to end harmful regulations while maintaining protections for students.The Department of Education is working to ensure regulations on the books adequately protect students while giving States, institutions, teachers, parents and students the flexibility they need to improve outcomes. The Dept. of Education has identified and withdrawn nearly 600 regulations that are deemed unnecessary.Secretary DeVos rescinded the 2011 Dear Colleague Letter and 2014 Q&A regarding Title IX enforcement, and interim guidance was issued. Secretary DeVos paused the Obama Administration’s Borrower Defense to Repayment and Gainful Employment regulations.The Department of Education’s Regulatory Review Taskforce identified nearly 600 outdated guidance documents for Secretary DeVos to rescind.August 2018 - The Department of Education announced $359.8 million in Federal assistance to 20 states and the U.S. Virgin Islands to assist with the cost of educating students displaced by Hurricane Harvey, Irma, Maria, or the 2017 California wildfires.August 2018 - The Department of Education announced that it would potentially rescind the Gainful Employment Regulation.The Department Of Education Claimed That The Removal Of This Regulation Would Help Provide Transparency And Fairness To Students In Higher Education.MAKING GOVERNMENT ACCOUNTABLE:President Trump is following through on his promise to drain the Washington swamp and make the Government accountable.President Trump fulfilled his promise and nominated Neil Gorsuch to the United States Supreme Court.President Trump has nominated over 75 Federal judges.Twenty-eight judges have been confirmed, including a record-setting 14 circuit judges.President Trump implemented higher ethical standards to make sure his Administration works for the American people.The President signed an Executive Order that placed a five-year ban on lobbying and a lifetime ban on lobbying for foreign countries.President Trump called for a comprehensive plan to reorganize the executive branch.President Trump began a comprehensive overhaul of digitally-delivered government services.President Trump called for a “full audit of the Pentagon.” The Department of Defense (DOD) responded to the President’s call to action, and began its full financial statement audit.Defense Secretary Jim Mattis called for business reform in the DOD to instill budget discipline and effective resource management.To ensure the Government serves the needs of all Americans, President Trump has called for a comprehensive plan to reorganize the executive branch and has begun to implement this plan.President Trump has commenced a comprehensive overhaul of digitally delivered Government services.President Trump has called for “conducting a full audit of the Pentagon.” The Department of Defense (DOD) responded to the President’s call to action and has begun its first full financial statement audit.Defense Secretary Jim Mattis has called for business reform in the DOD to instill budget discipline and effective resource management.FUNDING THE PRESIDENT'S PRIORITIES:$1.6 billion for border wall spending. This is the first time the wall has been funded since 2003.$703 million increase in ICE funding, from $6.4 billion to $7.1 billion, an increase of more than 10%.$4 billion to fight the opioid epidemic.$21 billion down payment on the President's promise to rebuild infrastructure.Despite Trump’s having obtained a $66 billion defense spending increase last year, bringing the total to $700 billion, the article below is sobering. As he said in reply to Michelle Obama, who wrote in her recent book that she’d never forgive him for his role in the birther narrative, “I'll never forgive Barack Obama for what he did to our United States military by not funding it properly. It was depleted. I came in and had to fix it.” And he did, but still there is much to do as the article below makes clear. And others make inane disparaging remarks…U.S. military might "struggle to win, or perhaps lose" war with China or Russia, report saysAmerica's military edge is diminished, and in some cases erased – just as rival countries are getting savvier, stronger and more aggressive, according to a new analysis by a panel of former security officials and military experts. The stark conclusion: America could lose the next war it fights."America's ability to defend its allies, its partners and its own vital interests is increasingly in doubt," the report's authors wrote. "It might struggle to win, or perhaps lose, a war against China or Russia."The panel is called the National Defense Strategy Commission, and is made up of 12 former national security officials and experts. It was tasked one year ago with evaluating the nation's defenses, and reviewing the National Defense Strategy, a comprehensive planning document by the Defense Department that lays out military objectives."Russia and China are challenging the United States, its allies and its partners on a far greater scale than has any adversary since the Cold War's end," the authors wrote. "If the United States had to fight Russia in a Baltic contingency or China in a war over Taiwan," the report warned. "Americans could face a decisive military defeat."Adversaries have studied U.S. military strategies post-9/11 – and learned how to counter them, said commission co-chair Eric Edelman, in an interview with Intelligence Matters host and CBS News senior national security contributor Michael Morell, who is also among the members of the commission and who helped write its report."They've learned from what we've done. They've learned from our success," said Edelman, former Under Secretary of Defense for Policy. "And while we've been off doing a different kind of warfare, they've been prepared for a kind of warfare at the high end that we really haven't engaged in for a very long time. What that means is that we can't fight traditionally, the way we have fought," he said.The commission identified a set of six trends it said had fundamentally altered the strategic environment now facing the United States:The return of major-power competition from authoritarian powers like Russia and China; The rise and expanded military capabilities of aggressive regional challengers like Iran and North Korea; Evolving and intensifying threats from jihadist groups; Rising "gray-zone" aggression, which includes strong-arm diplomacy and economic coercion, media manipulation and cyberattacks, paramilitary and proxy forces; Proliferation of advanced technology – hypersonics and AI, for instance – that is eroding U.S. advantages and creating new vulnerabilities; And political dysfunction – budgetary instability and reduced defense investment."We have basically been underfunding the Defense Department for quite a period of time," Edelman said. "I think there's been a disposition to believe that we spend so much money on defense [that] we should be able to deal with all comers. But what I think people have lost sight of is that the international environment has just become so much more complicated."The commission called for an increase in the defense budget of between 3-5 percent above inflation, or else "DOD should alter the expectations of the strategy and America's global strategic objectives."The report also recommended an independent commission be appointed to review U.S. cyber policy. "It is painfully clear that America is not competing or deterring its adversaries as effectively as it should in cyberspace," the report said."We've got to match the kind of intellectual firepower they're bringing to the problem with that kind of firepower of our own," Edelman told Morell.Previous defense strategy reviews had already issued warnings that America was risking national security crises if it did not better maintain or, in some cases, immediately bolster its military and operational capabilities.The 2018 commission said, however, that it believed America had already "reached the point of a full-blown national security crisis.""In this report," Edelman said, "I think what we had to wrestle with was the consequences of all those warnings having been ignored." The Defense Department said in a statement that it welcomed the release of the report and said it had "engaged extensively with the Commission throughout its deliberations." It said that the report's description of the security environment faced by the U.S. is "a stark reminder of the gravity of these issues, and a call to action." The Defense Department's statement went on to say it would "carefully consider each of the recommendations put forward by the Commission as part of continuing efforts to strengthen our nation's defense.The commission's co-chairs will testify about their findings before the Senate and House Armed Services Committees about the report's contents in late in December. That is available on the Web for anyone interested.