CH — LARRY ROMANOFF — 一连串的制药犯罪——第3部分——副作用和试验

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    A Litany of Pharma Crimes – Part 3 – Side Effects & Trials

    一连串的制药犯罪——第3部分——副作用和试验

     

    By Larry Romanoff, March 10, 2022

    拉里·罗曼诺夫,2022年3月10日

    译者珍珠

    Part 1, Part 2, Part 3,

    第一部分, 第二部分, 第三部分,

    CHINESE   ENGLISH

    It is becoming increasingly common that what are still called “side effects” are no longer any such thing but are instead more or less major features of these drugs and which affect increasingly larger percentages of users. If this trend continues, we will soon be at the point where any physical reaction will be considered a side effect if experienced by less than 50% of patients. It is most likely true that physical side effects have always been with us, there always being perhaps a few individuals whose body chemistry would respond in unexpected ways to new medications. But it is also true that these side effects, though sometimes horribly dramatic as with the drug Thalidomide, were mostly mild and rare, perhaps in part due to the simpler nature of the medications.

     现在越来越普遍的情况是,仍然被称为“副作用”的东西不再是这样的东西,而是这些药物或多或少的主要特征,影响着越来越多的使用者。如果这一趋势继续下去,我们很快就会发现,如果少于50%的患者出现任何身体反应,都将被视为副作用。最有可能的是,身体副作用一直伴随着我们,总有一些人的身体化学物质会对新药产生意想不到的反应。但同样正确的是,这些副作用,尽管有时像药物沙利度胺那样严重,但大多是轻微和罕见的,部分原因可能是药物的简单性质。

    Newer drugs are increasingly complex, less well understood in terms of their potential effects on body chemistry, and increasingly poorly researched with that research too often misrepresented and even falsified, the side effects too often dismissed as inconvenient anomalies instead of major inherent characteristics of these new drugs. It used to be that the normal range of unpleasant side effects might be experienced by only a fraction of one percent of the patient population, but the lust for profits has skewed the equation to the point where a drug will be developed by the pharma companies and approved by the FDA if even 10% or more than 20% of users experience harmful results.

     较新的药物越来越复杂,对其对身体化学的潜在影响的了解也越来越少,研究也越来越差,这些研究往往被曲解甚至伪造,副作用往往被视为不方便的异常现象,而不是这些新药的主要固有特征。过去,正常范围内的不愉快副作用可能只有1%的患者会经历,但对利润的渴望已经扭曲了这个等式,以至于即使有10%或20%以上的用户体验到有害结果,药物也将由制药公司开发并获得FDA批准。

    These so-called side effects of new and poorly-understood medications and vaccines are increasingly cutting a wide swath of death and injury through the populations of Western countries, especially in the dictatorial politically Right-Wing countries where big pharma has almost omnipotent influence like the US, Canada and the UK. These events are now termed “adverse drug reactions” or, more innocently-sounding, “ADRs”, and are estimated to cause well over 100,000 deaths per year in the US alone, making them one of the leading causes of death in America. (1) (2)

     这些新的、人们知之甚少的药物和疫苗的所谓副作用正在西方国家的人口中日益减少大量的死亡和伤害,尤其是在独裁的政治右翼国家,大型制药公司几乎拥有无所不能的影响力,如美国、加拿大和英国。这些事件现在被称为“药物不良反应”,或者更天真地说是“ADR”,据估计,仅在美国每年就造成超过10万人死亡,成为美国的主要死亡原因之一。(1) (2)

    According to the Journal of the American Medical Association, the incidence of “serious and fatal adverse drug reactions was found to be extremely high”. Researchers at the University of Toronto performed an analysis of studies at US hospitals for the past 30 years, to determine the frequency of harmful and unintended effects of medications, and found that nearly 10% of all hospitalised patients experienced at least one of these events every year, which would make this the fourth-largest cause of death in the country. The researchers noted their estimates are conservative, with no allowance for the administration of the drugs or other therapeutic failures. In other words, the deaths did not result from physician or pharmacist error, prescriptions of the wrong medication or accidental overdoses, but simply due to the already-known and often fatal side effects.

     据《美国医学会杂志》报道,“严重和致命的药物不良反应发生率极高”。多伦多大学的研究人员在过去30年对美国医院的研究进行了分析,以确定药物的有害和非预期影响的频率,并且发现每年有近10%的住院患者至少经历了这些事件中的一个。这将使其成为该国第四大死因。研究人员指出,他们的估计是保守的,没有考虑药物的服用或其他治疗失败。换句话说,这些死亡并不是由医生或药剂师的错误、错误用药的处方或意外过量引起的,而仅仅是由于已知且通常致命的副作用。

    In a report by the CDC published in 2007, and reviewed by Fox News and the Los Angeles Times, another analysis of US drug data found that the incidence of dangerous side effects and deaths from widely-used medications had tripled between 1998 and 2005, new potent pain-killers and arthritis drugs like Vioxx among the most dangerous. Both reports condemned the FDA’s lax or non-existent oversight on drug safety, especially noting its criminally-incompetent handling of Vioxx. One of the authors claimed “This growing toll of serious injury shows that the existing system is not adequately protecting patients and underscores the importance of recent reports urging far-reaching legislative, policy and institutional changes”.

     美国疾病控制与预防中心(CDC)在2007年发布的一份报告中,通过福克斯新闻(Fox News)和《洛杉矶时报》(Los Angeles Times)的审查,对美国药物数据的另一项分析发现,1998年至2005年间,广泛使用的药物导致的危险副作用和死亡的发生率增加了三倍,新型强效止痛药和关节炎药物(如万络)是最危险的药物。这两份报告都谴责FDA对药物安全的监管松懈或根本不存在,特别是指出其对万络的处理在刑事上不称职。其中一位作者声称,“不断增加的重伤人数表明,现有的制度没有充分保护患者,并强调了最近敦促进行深远的立法、政策和体制改革的报告的重要性”。

    During the period in question, the researchers discovered almost half a million serious drug-related complications. The FDA’s response was to say it was aware of the large numbers but had no explanation of the causes, except to offer the same foolish comment Obama made about people being killed by the police: “The police aren’t killing more people than before. It’s just that more people have mobile phones and communicate more.” The FDA made precisely the same comment, “Drugs aren’t killing more people this year than last year, but so many more people have iphones and Twitter accounts, and are telling everyone.”

     在这段时间里,研究人员发现了近50万种严重的药物相关并发症。FDA的回应是,它知道大量的死亡人数,但没有解释原因,只是提供了奥巴马关于被警察杀害的人的同样愚蠢的评论:“警察杀害的人没有比以前更多。只是更多的人拥有手机,交流更多。”FDA做出了完全相同的评论,“今年的药物致死人数并没有比去年多,但有更多人拥有iPhone和Twitter账户,并且告诉所有人。”

    When we combine these preventable deaths from flawed medications with the large death toll from hospital errors, (3) we have the largest single cause of death in the US. Even worse, “heart disease” – i.e., heart attacks – didn’t become the claimed “leading cause of death” by accident. If we correlate the astonishing increase in fatal cardiac events with the fallout from Vioxx, Zocor, Lipitor, the statins and all their cousins, we find a relationship of about 1:1, and that means the alarming increase in the incidence of fatal cardiac events was in no way a natural development but was directly caused by these new patented miracle drugs, the “miracle” being that some patients survive.

     当我们将这些可预防的由有缺陷的药物导致的死亡与因医院失误导致的大量死亡结合起来时(3)我们是美国最大的单一死因。更糟糕的是,“心脏病”——即心脏病发作——并不是偶然成为所谓的“主要死因”。如果我们将致死性心脏事件的惊人增加与万络、佐科、立普妥、他汀类药物及其所有近亲的沉降物相关联,我们发现两者之间的关系约为1:1,这意味着致命心脏事件发生率的惊人增长绝不是自然发展,而是由这些新的专利奇迹药物直接造成的,“奇迹”是一些患者存活下来。

    To add irony to tragedy, most of these drugs are marketed at least partially on their ability to prevent the heart attacks that they in fact cause. The pharma companies have conceived a scheme to defraud the national health systems by killing off half the population while their friends in the for-profit hospitals reap billions bankrupting the unfortunate survivors. Yet nobody cares to address this, the FDA, the badly compromised Congress, and the so-called “watchdog media” being especially conspicuous by their absence.

     让悲剧更具讽刺意味的是,这些药物中的大多数至少在一定程度上是基于其预防心脏病发作的能力。制药公司想出了一个骗取国家卫生系统的方案,杀死了一半的人口,而他们在营利性医院的朋友则从中获利数十亿,让不幸的幸存者破产。然而,没有人关心解决这个问题,食品和药物管理局、严重受损的国会以及所谓的“监督媒体”因其缺席而格外引人注目。

    In early 2015 Reuters ran an article by Kathryn Doyle on common heartburn medications like AstraZeneca’s Prilosec, known as proton-pump inhibitors (PPI), which demonstrated strong links to cardiac arrests. (4) The article stated that researchers sorted through more than 16 million clinical records for millions of adults to cross-link the usage of these medications and cardiac events and risks, and discovered about a 20% increased risk of heart attack in users of these PPI drugs. These medications are heavily prescribed for tens of millions of patients, resulting in sales of about $15 billion per year including OTC sales.

     2015年初,路透社刊登了凯瑟琳·道尔(Kathryn Doyle)的一篇文章,介绍了阿斯利康(AstraZeneca)的普洛赛克(Prilosec)等常见的胃灼热药物,即质子泵抑制剂(PPI),该药物与心脏骤停密切相关。(4)这篇文章指出,研究人员对数百万成年人的1600多万份临床记录进行了分类,将这些药物的使用与心脏事件和风险交叉联系起来,并发现使用这些PPI药物的人心脏病发作的风险增加了约20%。这些药物被大量用于数千万患者,每年的销售额约为150亿美元,包括非处方药销售额。

    This class of drugs is just one of many ‘new and improved’ patented medications that have been linked to greatly increased cardiac risks. There seems to be little point in disputing the claim that many or most modern medications are complex, poorly understood, have lethal side effects, are inadequately researched and tested, are subject to grossly inadequate supervision and oversight, and are often placed on the market far too quickly. The same is true for vaccines, one of the serious criticisms (and fears) of the recent COVID-19 remedies. Moreover, the lethal side effects are far too often proven to have been known by the drug manufacturers in advance of FDA approval but that this information was suppressed.

     这类药物只是许多“新的和改进的”专利药物中的一种,这些药物与大大增加的心脏病风险有关。对许多或大多数现代药物都很复杂、了解甚少、有致命的副作用、研究和测试不足、监管和监督严重不足、上市速度往往过快的说法,似乎没有什么争议。疫苗也是如此,这是最近COVID-19补救措施的严重批评(和恐惧)之一。此外,在FDA批准之前,药物制造商往往已经知道致命的副作用,但这些信息被隐瞒了。

    In part due to the landscape that has emerged from these dishonest and illegal activities, it is not only patients but also physicians who are in the dark about the dangers of modern medicines. Physicians of my acquaintance in Canada and the US seem to obtain most or all of their information from a “medical website for doctors” that depends almost entirely on content provided directly by the pharma companies or indirectly by physicians paid by them to produce that content. One example of the result:

     在一定程度上,由于这些不诚实和非法活动所呈现的景象,不仅患者,而且医生对现代药物的危险一无所知。我在加拿大和美国认识的医生似乎从一个“医生医疗网站”获得了大部分或全部信息,该网站几乎完全依赖于制药公司直接提供的内容,或由他们付费制作该内容的医生间接提供的内容。结果的一个例子:

    I spoke with some Western physicians about the use of PPIs, and was alarmed to discover some viewed these as almost a casual substitute for antacid medication for those suffering from indigestion. I did some research and my first discovery was a chemical-biological report stating that PPI’s “make profound and irreversible changes to the body’s system.” I reported this to the said physicians who observed (a) “I had no idea”, (b) (disparagingly) “I don’t know what website you were looking at”, (c) “You do more research than I do.”

     我与一些西医讨论了PPI的使用,并震惊地发现一些人认为PPI几乎是消化不良患者抗酸药物的临时替代品。我做了一些研究,我的第一个发现是一份化学生物学报告,指出PPI“对身体系统造成深刻而不可逆转的变化”我向上述医生报告了这一点,他们观察到(a)“我不知道”;(b)(轻蔑地)“我不知道你在看什么网站”;(c)“你做的研究比我多。”

    To my mind, it is the FDA that should be sued in these instances since it carries the ultimate responsibility for public safety in food and drugs, but appears to have abandoned virtually all that responsibility to the pharma companies in spite of the knowledge that they almost always lie, frequently fabricate their test data, and almost always bury the truth of side effects for as long as possible. When faced with a situation where a potential 5% of patients might suffer death or debilitating injury, the FDA’s responsibility is to remove a drug from the market, but its loyalties to the pharma industry outweigh those to the general public. Even if a medication were so vital for some illnesses that its use justified the serious risks, it is unconscionable to permit off-label applications that unnecessarily expose millions of otherwise healthy individuals to totally unnecessary and severe risks. And if the FDA isn’t policing these concerns, of what use is it?

     在我看来,在这些情况下,应该起诉的是FDA,因为它对食品和药品的公共安全负有最终责任,但似乎已经放弃了制药公司几乎所有的责任,尽管他们知道他们几乎总是撒谎,经常编造测试数据,而且几乎总是尽可能长时间地掩盖副作用的真相。当面临可能有5%的患者死亡或受伤时,FDA的责任是将药物从市场上移除,但它对制药行业的忠诚超过了对公众的忠诚。即使一种药物对某些疾病非常重要,以至于它的使用证明了严重风险的合理性,但允许非标签应用不必要地让数百万原本健康的个体面临完全不必要的严重风险,也是不合情理的。如果FDA不监管这些问题,那又有什么用呢?

    Clinical Trials of Pharmaceuticals

    药物临床试验

    By the 1980s, American (and European) pharmaceutical companies began to experience a serious bottleneck in their headlong rush to bring new drugs to the market, in that test trials on live human subjects were becoming impossible due in part to the reluctance of a population to act as guinea pigs for experimental drugs, and to the massive lawsuits arising from toxic medications. They therefore did what any criminal psychopath would do. They began outsourcing their clinical drug trials to poor countries on the financially-sound but morally bankrupt theory that killing Asians and Africans was better and cheaper than killing whites. They outsourced their live trials to the poorest and least developed countries with low literacy, insufficient legal restraints, and a totally unjustified faith in the White Man’s Medicine and the ethical standards of Americans. Even better, with these foreign trials, there is a complete absence of oversight from the FDA and, most importantly, the full protection of the US State Department when things go wrong. This will be more fully referenced in subsequent articles on the FDA and Pfizer.

     到了20世纪80年代,美国(和欧洲)制药公司开始经历一个严重的瓶颈,他们急急忙忙地将新药推向市场,在这种情况下,对活体人体受试者的试验变得不可能,部分原因是一个群体不愿充当实验药物的豚鼠,以及有毒药物引发的大规模诉讼。因此,他们做了任何犯罪精神病患者都会做的事情。他们开始将临床药物试验外包给贫穷国家,依据的是财务状况良好但道德败坏的理论,即杀死亚洲人和非洲人比杀死白人更好、更便宜。他们将现场试验外包给了最贫穷和最不发达的国家,这些国家的识字率低,法律约束不足,对白人的医学和美国人的道德标准抱有完全不合理的信念。更妙的是,在这些国外试验中,FDA完全没有监督,最重要的是,在出现问题时,美国国务院完全没有保护。这将在随后关于FDA和辉瑞的文章中得到更充分的引用。

    The financial cost of testing in these countries is much lower since neither the laws nor government oversight practices have developed to a level useful for public protection, and these corporations can easily – and often do – suppress research that demonstrates harmful side effects, choosing to report only positive results. In the ten years to 2008, the number of overseas clinical trials by US pharma companies were in the many thousands, having increased by 20 times. These trials, which are almost never monitored by the US FDA or any other body, are usually conducted in areas with large numbers of poor and illiterate people who grant their consent by signing an “X” or making a thumb print on a form. In a great many cases these tests prove deadly, resulting in thousands of deaths, especially among babies. In each case, the US pharma companies simply return home, absolving themselves of any responsibility for the carnage they leave behind.

     在这些国家,检测的财务成本要低得多,因为法律和政府监督实践都没有发展到有助于公共保护的水平,而且这些公司可以很容易地——而且经常这样做——抑制显示有害副作用的研究,选择只报告积极的结果。在截至2008年的十年间,美国制药公司的海外临床试验数量达到了数千项,增长了20倍。这些试验几乎从未受到美国食品和药物管理局或任何其他机构的监督,通常是在有大量穷人和文盲的地区进行的,他们通过在表格上签署“X”或留下拇指指纹来表示同意。在很多情况下,这些测试被证明是致命的,导致数千人死亡,尤其是婴儿。在每一个案例中,美国制药公司都只是回家,免除自己对留下的大屠杀的任何责任。

    In 2012, NBC reported on a year-long study they conducted in India, where drugmakers are increasingly going to do their human drug testing. (5) (6) When pharmaceutical companies need a supply of test victims for clinical drug trials, they turn to human ‘recruiters’ who are paid about $12 for each person they bring to the research labs. NBC’s study claims that this way the US pharma companies “save millions of dollars, avoid regulatory scrutiny and tap into a seemingly endless supply of drug study participants”. But the absence of oversight raises serious questions about the integrity of the firms and the reliability of their test data.

     2012年,NBC报道了他们在印度进行的一项为期一年的研究,制药商越来越多地在印度进行人体药物测试。(5) (6)当制药公司需要为临床药物试验提供测试受害者时,他们会求助于人类“招聘人员”,他们为每个带到研究实验室的人支付大约12美元。NBC的研究称,通过这种方式,美国制药公司“节省了数百万美元,避免了监管审查,并利用了看似无穷无尽的药物研究参与者”。但缺乏监管引发了对这些公司的完整性及其测试数据可靠性的严重质疑。

    NBC and others claim that most of these recruits are so desperately poor they disregard the risks, if indeed they appreciate that risks even exist, recruiters claiming they ignore the side effects of the drugs because they need the money. The study indicated that subjects can earn as much as $400 for participation in a long study, an amount that “far outstrips traditional earnings”, and that many participate in numerous trials simultaneously, which negates the value of the data as well as putting the participants in mortal danger, but which fact the testing companies ignore. There are many stories of test subjects suffering serious complications like loss of eyesight and failure of internal organs, and of course there are many deaths, with these unpleasantries ignored and unrecorded.

     NBC和其他公司声称,这些新兵中的大多数都非常贫穷,他们忽视了风险,如果他们真的意识到风险甚至存在的话,招聘人员声称他们忽略了药物的副作用,因为他们需要钱。这项研究表明,受试者参加一项长期研究可以赚取高达400美元的收入,这一数额“远远超过传统收入”,而且许多人同时参加了许多试验,这否定了数据的价值,也使受试者面临致命的危险,但测试公司忽视了这一事实。有很多关于受试者遭受严重并发症的故事,比如视力丧失和内脏器官衰竭,当然也有很多人死亡,这些不愉快的事情被忽略和记录在案。

    Observers claim the almost total lack of government oversight “has created a culture of impunity for drug research companies and the doctors who work for them”, though the US pharma companies hollowly claim that “international standards” are always followed. The situation seems to be that these outsourced tests do not fall under FDA jurisdiction, and the Indian government generally is either unaware of them or turns a blind eye, even in the frequent event of death. This means, among other things, that the data are not only unreliable in themselves but are often fabricated to suit the sponsoring pharma company’s expectations. The report revealed the startling fact that the FDA inspects less than 1% of all drug trial sites, either domestic or foreign, and that the agency has no clear idea of what occurs during any of these tests. Yet the FDA depends entirely on the data produced by these trials for its decisions on approval of new medications, despite the vast evidence that much of these data – both domestic and foreign – are faked.

     观察人士称,几乎完全缺乏政府监督“为药物研究公司及其工作的医生创造了一种有罪不罚的文化”,尽管美国制药公司虚张声势地宣称,它们总是遵循“国际标准”。目前的情况似乎是,这些外包检测不属于FDA的管辖范围,印度政府通常要么不知道,要么视而不见,即使是在频繁发生死亡事件的情况下。这意味着,除其他外,数据本身不仅不可靠,而且往往是捏造的,以满足赞助制药公司的期望。该报告揭示了一个令人震惊的事实,即FDA检查了不到1%的所有药物试验地点,无论是国内还是国外,而且该机构对这些试验中发生的情况没有明确的了解。然而,FDA完全依赖这些试验产生的数据来决定是否批准新药,尽管有大量证据表明,这些数据——无论是国内还是国外的——都是伪造的。

    To conduct an investigation, NBC News created a fake pharmaceutical company and sent some of their correspondents to India to examine the circumstances and conditions in which American pharma companies execute their outsourced live drug trials. They produced fake documentation for a drug that was clearly Vioxx, the Merck medication that was eventually pulled from the market after being proven lethal. They met with executives of a major ‘therapeutic research’ firm that agreed to perform extensive live trials on unwitting subjects – for a fee of a million dollars. The firm agreed it was risky, but assured NBC they could bribe a well-connected medical consultant to obtain government approval for the trials. The firm boasted that the test subjects would be paid a total of $150 for participation in the entire study, as opposed to a cost of $150 per day if done in the US.

     为了进行调查,NBC新闻创建了一家假制药公司,并派了一些记者前往印度,调查美国制药公司执行外包的活体药物试验的情况和条件。他们为一种显然是万络(Viox)的药物制作了假文件,这是默克公司的一种药物,在被证明是致命的后,最终被从市场上撤出。他们会见了一家大型“治疗研究”公司的高管,该公司同意对不知情的受试者进行广泛的现场试验,费用为100万美元。该公司同意这有风险,但向NBC保证,他们可以贿赂一位关系密切的医疗顾问,以获得政府对试验的批准。该公司吹嘘说,参加整个研究的受试者将获得总计150美元的报酬,而在美国,每天的费用为150美元。

    When NBC presented these facts and a full video to the FDA, they were told of course this kind of conduct was unacceptable but appeared to be outside the range of the FDA’s influence even though the test results, in a real situation, would be used for FDA certification of a new drug. Doug Peddicord, director of an industry-promoting NGO, defended the pharma industry, claiming, “the clinical research enterprise is amazingly safe and amazingly productive”, that unethical conduct “would never be tolerated” by pharma companies and made an undocumented historical claim to the effect that any such unethical firms have always rapidly gone out of business, all claims that were clearly rubbish.

     当NBC向FDA提交这些事实和完整视频时,他们被告知这种行为当然是不可接受的,但似乎超出了FDA的影响范围,即使在真实情况下,测试结果将用于FDA对新药的认证。一家促进行业发展的非政府组织的负责人道格·佩迪科德(Doug Peddicord)为制药行业进行了辩护,声称“临床研究企业非常安全,生产效率也非常高”,制药公司“永远不会容忍”这种不道德的行为,并提出了一个未经记录的历史主张,大意是任何此类不道德的公司总是迅速倒闭,所有这些主张显然都是垃圾。

    The problem is that the FDA is in no position to evaluate the companies doing the trials, and base their conclusions only on the reported results which are repeatedly proven to have been falsified. The FDA refused to be interviewed for these programs, but blandly claimed they were “strongly engaged in the clinical research process” in all stages, another claim that is clearly false.

     问题是,FDA无法对进行试验的公司进行评估,只能根据报告的结果得出结论,这些结果被反复证明是伪造的。FDA拒绝就这些项目接受采访,但温和地声称他们在所有阶段都“积极参与临床研究过程”,另一种说法显然是错误的。

    Al Jazeera conducted a similar investigation that confirmed NBC’s experience. (7) Both groups noted that physicians in India are revered and their recommendations almost never questioned by the population, making it exceedingly easy for them to use their own patients as unwitting victims in these drug trials – the same process Peddicord wants to create in the US. They noted that US pharma companies arrange to conduct many of their trials at hospitals where physicians have been recruited through simple bribery, offering opportunities for both the doctors and the hospitals to earn important sums of money. A few small studies by one hospital can collect several hundred thousand dollars, some of which is shared by the doctors and which represents a pittance to the pharma companies when compared to these costs in the US. Al Jazeera reported interviewing doctors who claimed the US pharma companies had paid them and many colleagues to conduct these trials on their patients, and had also given these doctors all-expense paid trips to the US and other Western countries, as both incentive and reward.

     半岛电视台进行了类似的调查,证实了NBC的经验。(7)这两个组织都指出,印度的医生受到尊重,他们的建议几乎从未受到民众的质疑,这使得他们在这些药物试验中极易将自己的患者作为无意中的受害者——佩迪科德希望在美国创造同样的过程。他们指出,美国制药公司安排在通过简单贿赂招募医生的医院进行许多试验,这为医生和医院都提供了赚大钱的机会。一家医院的几项小型研究可以筹集数十万美元,其中一些由医生分担,与美国的这些成本相比,这对制药公司来说是微不足道的。半岛电视台报道采访了一些医生,他们声称美国制药公司付钱给他们和许多同事,让他们在患者身上进行这些试验,还让这些医生自费前往美国和其他西方国家,作为奖励和奖励。

    Both Al Jazeera and NBC commented on the apparent total lack of empathy for the victims of these studies, many of whom end up suffering horribly or dying. Al Jazeera interviewed one woman who lost both her daughters after they were vaccinated with Merck’s Gardasil, and found many other mothers with the same tales. There were no examinations, no follow-ups, and no prosecutions. The government quickly found nobody responsible for the deaths of these girls, and refused to blame Merck’s vaccine.

     半岛电视台和NBC都对这些研究的受害者显然完全缺乏同情心发表了评论,其中许多人最终遭受了可怕的痛苦或死亡。半岛电视台采访了一名在默克公司的Gardasil疫苗接种后失去两个女儿的妇女,发现许多其他母亲也有同样的故事。没有检查,没有跟进,也没有起诉。政府很快发现没有人对这些女孩的死亡负责,并拒绝指责默克公司的疫苗。

    In their attempt to paint black as white, to portray big pharma as benevolent fairy, and to engender sympathy for the companies that are simultaneously killing us and stealing our money, the US corporate media never tire of telling us that bringing a new drug to market can cost billions and require 20 years of research and testing. I doubt there has been even one such real example, but in any case, many medications can be brought to market in six weeks at the cost of a few tens of thousands of dollars. Newspaper columnists never tell us the range or the average of drug development costs, always stating the worst possible case as a typical example.

     美国企业媒体试图把黑色描绘成白色,把大型制药公司描绘成仁慈的仙女,并对那些同时杀害我们和窃取我们资金的公司表示同情,他们总是不厌其烦地告诉我们,将一种新药推向市场可能需要数十亿美元,需要20年的研究和测试。我怀疑甚至有这样一个真实的例子,但无论如何,许多药物可以在六周内以几万美元的价格推向市场。报纸专栏作家从不告诉我们药物开发成本的范围或平均值,总是以最坏的情况为典型例子。

    We’re then told the costliest and most time-consuming portion of drug development is the clinical testing phase, the live trials, these being heavily promoted by industry insiders appealing to our humanity in a desperate effort to equate humanity with the process of filling the pockets of the inhuman. One such person, a Dr. Diana Anderson, tells us “Without people who are willing to participate there would be no process to test new medicines, vaccines, and devices, [and that] without testing on human subjects, there wouldn’t be any new drugs made available to the public.” That may be true, but the real purpose of these clinical trials is to count the number of dead bodies and the number of unfortunate survivors who suffer a progressive collapse of all their internal organs from the injection of yet another expensive wonder drug. In any case Dr. Anderson lost me when she claimed clinical trials were conducted by “the strict rules and regulations mandated by the FDA”. After I stopped laughing, I wanted to cry.

     然后我们被告知,药物开发中最昂贵、最耗时的部分是临床试验阶段,即现场试验,这些都是由业内人士大力推动的,他们呼吁我们的人类不顾一切地努力将人类等同于填满非人道者口袋的过程。其中一位名叫戴安娜·安德森(Diana Anderson)的人告诉我们,“没有愿意参与的人,就不会有测试新药、疫苗和设备的过程,[而且]没有对人体进行测试,就不会有任何新药向公众提供。”这可能是正确的,但这些临床试验的真正目的是计算死亡的尸体数量和不幸的幸存者,他们的内脏器官不断地被注射,而另一种昂贵的特效药也被注射。无论如何,当安德森博士声称临床试验是按照“FDA强制执行的严格规则和条例”进行时,她失去了我。在我停止笑后,我想哭。

    Industry-financed NGOs tell us the real problem is that pharma companies are unskilled in public relations, that “better communication” is needed to educate people about the benefits of clinical trials. Someone named Ken Getz, a Jew, Chairman of one such NGO with a long name, tells us these firms need to be more personal, with responses that reflect “heart and compassion”, so that the general public, consisting of tens of millions of potentially-gullible volunteers will offer to self-immolate for the benefit of humanity, i.e., the profits of the pharma companies. Getz’s non-profit NGO was formed “to raise awareness of clinical trials”, to educate the public and remove any stigma against testing on humans. He tells us 80% of volunteers never again take part in a clinical drug trial, a result he terms “a harsh trend that the industry is desperate to reverse”, but without offering the reasons for that harsh trend. Getz even wrote a book titled ‘The Gift of Participation’, not specifying that ‘participation’ was a gift to the pharma companies and not to the victims.

     行业资助的非政府组织告诉我们,真正的问题是制药公司在公共关系方面缺乏技能,需要“更好的沟通”来教育人们认识到临床试验的好处。一个名叫肯·盖茨的犹太人,是一个名字很长的非政府组织的主席,他告诉我们,这些公司需要更加个人化,做出反映“内心和同情心”的回应,这样,由数千万可能容易上当受骗的志愿者组成的公众将为了人类的利益而自焚,即:。,制药公司的利润。Getz的非营利非政府组织成立的目的是“提高临床试验的意识”,教育公众,消除对人体试验的任何污名。他告诉我们,80%的志愿者再也没有参加过临床药物试验,他称这是一个“行业迫切想要扭转的严峻趋势”,但没有给出这种严峻趋势的原因。Getz甚至写了一本书,名为《参与的礼物》,没有具体说明“参与”是给制药公司的礼物,而不是给受害者的礼物。

    He feels “the pharma community” (note how these Satan-worshippers have now become almost family) needs to pro-actively educate the public about big pharma’s need for more profits and the role played by clinical trial victims in this. He believes the industry should communicate “the positive benefits” from trials, saying “There are so many good things to report …”. Yes, and a few bad ones.

     他认为“制药界”(注意到这些撒旦崇拜者现在几乎成了一家人)需要积极地教育公众,让他们了解大型制药公司对更多利润的需求,以及临床试验受害者在这方面所起的作用。他认为,该行业应该传达试验带来的“积极好处”,并表示“有太多好的事情要报道……”。是的,还有一些不好的。

    And we have another NGO called the Association of Clinical Research Organizations, headed by the same Douglas Peddicord, whose surveys tell him the greatest barrier to participating in clinical trials is not fear of death or massive organ collapse, but a lack of knowledge about opportunities to participate, the great gullible public eager to take a shot and see what happens but apparently have no idea how or where – to the great detriment of both humanity and pharma profits. Peddicord apparently believes it is a responsibility of family doctors to “accurately and positively” educate their patients as to the benefits of being a guinea pig. So now our family doctors are to be recruited as the front-line soldiers, taking unfair advantage of the public’s natural gullibility and its no-longer-justified trust in physicians, to line up all their patients for the latest kidney-failure lottery.

     我们还有另一个名为临床研究组织协会的非政府组织,由同一位道格拉斯·佩迪科德领导,他的调查告诉他,参与临床试验的最大障碍不是害怕死亡或大规模器官衰竭,而是缺乏参与机会的知识,容易上当受骗的公众渴望试一试,看看会发生什么,但显然不知道如何或在哪里——这对人类和制药公司的利润都是巨大的损害。佩迪科德显然认为,家庭医生有责任“准确、积极地”教育患者成为一只豚鼠的好处。因此,现在我们的家庭医生将被招募为前线士兵,利用公众天生容易受骗的不公平优势,以及公众对医生不再合理的信任,让所有患者排队参加最新的肾衰彩票。

    Our Dr. Diana Anderson envisions “a fully-integrated marketing approach” (if it’s America, it’s always just marketing) containing “a multitude of effective strategies”. Of course, marketing may not help as much as Dr. Anderson evidently hopes. Increasingly in the West, people are fully aware of the dangers of ingesting untested medications and increasingly terrified of “warp-speed” vaccines, with increasingly fewer willing to take potentially serious physical risks in spite of their intense desire to enhance big pharma’s profits. Hardly anybody much cares about the needs of the pharma companies and hardly anybody needs a few dollars badly enough to risk the perils of medicines. But an equal problem is that the ‘unexpected and unforeseen’ fatal or otherwise side effects of these medications have led to increasingly huge lawsuits and court awards, to the extent that the pharma companies no longer want the volunteers in spite of their desperate need.

     我们的戴安娜·安德森(Diana Anderson)博士设想了一种“完全整合的营销方法”(如果是美国,它总是只是营销),其中包含“多种有效的策略”。当然,营销可能没有安德森博士所希望的那么大帮助。在西方,人们越来越充分地意识到摄入未经测试的药物的危险,越来越害怕“曲速”疫苗,尽管他们强烈希望提高大型制药公司的利润,但愿意承担潜在严重身体风险的人越来越少。几乎没有人关心制药公司的需求,也几乎没有人急需几美元来承担药品风险。但同样的问题是,这些药物的“意外和不可预见的”致命或其他副作用已经导致越来越多的诉讼和法庭裁决,以至于制药公司不再需要志愿者,尽管他们迫切需要。

    Mr. Rogers tells us that “while human testing will continue to be the most costly and time-consuming aspect of drug development, it is the only way that drug development can move forward. New medicines have to be tested on people to see if they work – it’s as simple as that.” And, in one of the most reprehensibly disingenuous statements I’ve ever seen, he said:

     罗杰斯先生告诉我们“虽然人体试验将继续是药物开发中最昂贵、最耗时的方面,但这是药物开发取得进展的唯一途径。新药必须在人身上进行试验,看看它们是否有效——就这么简单。”在我所见过的最不诚实的声明中,他说:

    “For the pharmaceutical company involved it can be a bitter pill to swallow if all the years of hard work and resources have come to nothing. But as Merck found out to its cost, any side effects are best unearthed in the laboratory or during a clinical trial than on the market.”

     “对于相关制药公司来说,如果多年的辛勤工作和资源都付诸东流,这可能是一个难以下咽的苦果。但默克公司发现,任何副作用最好在实验室或临床试验中发现,而不是在市场上发现。”

    The truth is that Merck “unearthed” Vioxx’s side effects long before the drug went on sale, but the salient point is that what Merck actually “found out” is that it’s profitable as hell to market a flawed medication, kill hundreds of thousands of people, make tens of billions in profits, then pay a small penalty while “neither admitting nor denying” anything.

     事实是,早在万络上市之前,默克就“发现”了它的副作用,但最重要的是,默克实际上“发现”的是,销售一种有缺陷的药物,杀死数十万人,赚取数百亿美元的利润,然后支付一小笔罚款,同时“不承认也不否认”任何事情。

    Let’s review. US regulations demand clinical trials of new medications be performed on live humans. Many new medications produce fatal or otherwise disastrous side effects (aka unforeseen anomalies) during these trials. US courts don’t generally consider these anomalies to have been quite as unforeseen as did the pharma companies, leading to huge financial settlements. Westerners are now far better informed and educated than in days gone by, and few are now interested in offering themselves as 50% profit incubator and 50% potential corpse. So much bad news. A problem with no solution.

     让我们回顾一下。美国法规要求在活体人体上进行新药临床试验。在这些试验中,许多新药会产生致命的或灾难性的副作用(即无法预见的异常)。美国的法院一般不认为这些异常现象与制药公司一样难以预料,导致巨大的财务结算。西方人现在比过去有了更多的知识和教育,现在很少有人有兴趣把自己作为50%的利润孵化器和50%的潜在尸体。这么多坏消息。没有解决办法的问题。

    But then everything has a bright side, every cloud with its own silver lining. Mr. Rogers happily tells us that “while the diminishing number of volunteers is proving a headache for the pharmaceutical companies and researchers, increasingly they are outsourcing human testing to the developing world. India, for instance, is flourishing as clinical trials hotbed.” He notes truthfully that “Critics argue that volunteers (in the developing world) are naive about the potential consequences of human testing and that some trials are illegal”, but then dismisses this inconvenient truth and proceeds to happier things.

     但每件事都有光明的一面,每一片乌云都有自己的光明。罗杰斯愉快地告诉我们,“虽然志愿者人数的减少让制药公司和研究人员感到头疼,但他们越来越多地将人体试验外包给发展中国家。例如,印度正蓬勃发展,成为临床试验的温床。”他如实地指出,“批评人士认为(发展中国家的)志愿者对人体试验的潜在后果很幼稚,有些试验是非法的”,但随后否认了这一令人不安的事实,并开始做更快乐的事情。

    Our Dr. Diana Anderson, always the optimist, hopes the Indians’ “enthusiasm to participate” in their own deaths and organ failures will be contagious to the Americans, stating “I also hope and believe that as the general public here in the U.S. becomes more aware of the benefits of participating in clinical trials that we will see greater levels of participation in the future”. But she saves her best hopes for the undeveloped world, telling us “Within the last few months I’ve been fortunate enough to travel to China and India as well as other emerging markets and I’ve seen first-hand the momentum and enthusiasm for clinical trials that is taking place in these countries. They have enormous populations and they are very willing to participate in clinical trials. This is an exciting time to be involved in the clinical trials industry and I’m very optimistic about our future.” Not to be mean-spirited, but I fervently pray that dear Diana’s hopes and enthusiasm are both dashed by reality, by strict government intervention, and by long prison sentences.

     我们的戴安娜·安德森博士一直是乐观主义者,她希望印度人对自己死亡和器官衰竭的“参与热情”能够传染给美国人,声明“我也希望并相信,随着美国公众越来越意识到参与临床试验的好处,我们将在未来看到更高水平的参与”。但她把最大的希望留给了不发达的世界,告诉我们“在过去的几个月里,我有幸前往中国、印度以及其他新兴市场,亲眼目睹了这些国家正在进行的临床试验的势头和热情。这些国家人口众多,非常愿意参与临床试验。这是一个令人兴奋的趋势。”我希望参与临床试验行业,我对我们的未来非常乐观。“我不想吝啬,但我热切地祈祷亲爱的戴安娜的希望和热情都被现实、严格的政府干预和长期监禁所粉碎。

    And Mr. Rogers, apparently equally an optimist, tells us that even the news of deaths, organ collapses, cancers and other misfortunes will not discourage clinical trial “regulars” from participating in these injectable lotteries of life. He tells us almost breathlessly that “Some regulars use [drug] trials as a second income, while backpackers see it as a way of funding the next leg of their travels”. A second income sounds good. Keep the wife at home with the kids, and still afford that new car. And now every university student can take a gap year and travel the world without concern for finances; first thing when you hit Rome, just call Merck or Pfizer and tell them you need cash.

     罗杰斯显然也是一位乐观主义者,他告诉我们,即使是死亡、器官衰竭、癌症和其他不幸的消息,也不会阻止临床试验“常客”参与这些生命的可注射彩票。他几乎上气不接下气地告诉我们,“一些常客将[药物]试验作为第二收入,而背包客则将其视为资助下一段旅程的一种方式”。第二份收入听起来不错。让妻子和孩子们待在家里,而且还买得起那辆新车。现在,每个大学生都可以在不担心经济问题的情况下利用空档年环游世界;当你去罗马的时候,第一件事就是打电话给默克或辉瑞,告诉他们你需要现金。

    We can understand when Peddicord claims “the controlled clinical trial represents the single greatest advance in the science of medicine in our time”. A great advance not only for medical science, but apparently for the auto and travel industries as well.

    我们可以理解佩迪科德声称“对照临床试验代表了我们这个时代医学科学的最大进步”。这不仅是医学的一大进步,显然也是汽车和旅游业的一大进步。

    Note to Readers: The above-referenced articles and quotations by Peddicord, Rogers, Anderson et al, appear to have been scrubbed from the internet.

     读者注意:上述引用的文章和引用的佩迪科德,罗杰斯,安德森等人,似乎已从互联网上删除。

    Off-Label Promotion

    标签外促销

    When a pharma company receives FDA approval for a drug, that approval is restricted to specified intended uses only, and cannot be promoted for any other use or purpose. Promotion for non-approved uses is known as “off-label promotion” and is illegal. To quote an article from Forbes:

     当制药公司获得FDA对某一药物的批准时,该批准仅限于特定的预期用途,不能用于任何其他用途或目的。对于未经批准的用途的促销被称为“标签外促销”,是非法的。引用《福布斯》的一篇文章:

    “In recent years, the government’s response to the practice has culminated in significant payments for drugmakers caught promoting off-label prescriptions. In 2007, Bristol-Myers Squibb paid out $515 million to settle various civil allegations including its promotion of the antipsychotic drug, Abilify. Two years later, Eli Lilly paid out $1.415 billion in part for its off-label marketing of Zyprexa. Last summer, GlaxoSmithKline agreed to plead guilty to criminal charges and pay out $3 billion to settle various government claims, including the unlawful promotion of some of its drugs, like the popular anti-depressant Paxil. The amount marked the largest health care fraud settlement in the nation’s history.

    “近年来,政府对这一做法的回应最终导致向被抓获推广非标签处方药的制药商支付大笔款项。2007年,百时美施贵宝支付了5.15亿美元,以解决各种民事指控,包括其推广抗精神病药Abilify。两年后,礼来支付了1.415亿美元部分原因是Zyprexa的非标签营销。去年夏天,葛兰素史克同意承认刑事指控,并支付30亿美元以解决政府的各种索赔,包括非法推广其一些药物,如流行的抗抑郁药帕罗西汀。这是美国历史上最大的医疗欺诈和解案。

    J&J’s Risperdal was the latest target on the government’s list. [The company’s] marketing efforts paid dividends. Sales of Risperdal skyrocketed from $172 million in 1994 to $1.726 billion in 2005; in 2000, it was J&J’s second-best selling drug, with 75% of the sales coming from off-label prescriptions, according to court documents. According to some estimates, off-label prescriptions account for 20 percent of all sales, totaling more than $40 billion in sales annually. The practice is simply too lucrative to pass up.” And of course, Forbes is correct in its statements. Industry analysts estimated that J&J has gathered in about $25 billion from Risperdal since it went on sale in 2003. In this light, a fine of $2 billion is a small sales tax like a VAT.” (8) access denied

     强生的利培酮是政府名单上的最新目标。(该公司)的营销努力获得了回报。利培酮的销售额从1994年的1.72亿美元飙升至2005年的17.26亿美元;根据法庭文件,2000年,它是强生的第二畅销药,75%的销售额来自非标签处方。据估计,非标签处方药占总销售额的20%,每年总销售额超过400亿美元。这种做法太有利可图了,不能放弃。“当然,《福布斯》的说法是正确的。行业分析人士估计,自2003年利培酮上市以来,强生已经从利培酮那里获得了约250亿美元的收入。因此,20亿美元的罚款是一种类似增值税的小额销售税。”(8)拒绝访问

    Next: Part 4 –US Pharma in China

    下一篇:4部分——美国制药公司在中国 

    *

    Mr. Romanoff’s writing has been translated into 32 languages and his articles posted on more than 150 foreign-language news and politics websites in more than 30 countries, as well as more than 100 English language platforms. Larry Romanoff is a retired management consultant and businessman. He has held senior executive positions in international consulting firms, and owned an international import-export business. He has been a visiting professor at Shanghai’s Fudan University, presenting case studies in international affairs to senior EMBA classes. Mr. Romanoff lives in Shanghai and is currently writing a series of ten books generally related to China and the West. He is one of the contributing authors to Cynthia McKinney’s new anthology ‘When China Sneezes’. (Chapt. 2 — Dealing with Demons).

    罗曼诺夫先生的作品已被翻译成32语言,他的文章发布在30多个国家的150多个外语新闻和政治网站上,以及100多个英语平台上。拉里·罗曼诺夫是一位退休的管理顾问和商人。他曾在国际咨询公司担任高级管理职位,并拥有国际进出口业务。他曾是上海复旦大学的客座教授,向高级EMBA课程介绍国际事务的案例研究。罗曼诺夫住在上海,目前正在撰写一系列十本书,内容大致与中国和西方有关。他是辛西娅·麦金尼新文集的撰稿人之一“当中国打喷嚏时”(第2章-对付恶魔).

    His full archive can be see at https://www.bluemoonofshanghai.com/  + https://www.moonofshanghai.com/  

    他的完整档案可在https://www.bluemoonofshanghai.com/  + https://www.moonofshanghai.com/  

    He can be contacted at: 2186604556@qq.com

    联系方式如下:2186604556@qq.com

    *

    NOTES

    Notes Pharma Part 3

    注制药第3部分

    (1)    https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2898%2923016-9/fulltext

    Adverse drug reactions remain a major cause of death

    药物不良反应仍然是导致死亡的主要原因

    (2) https://californiahealthline.org/morning-breakout/adverse-drug-reactions-a-leading-cause-of-death-study-says-endstoryhed/

    ADVERSE DRUG REACTIONS: A Leading Cause Of Death

    药物不良反应:主要死亡原因

    (3) https://www.bluemoonofshanghai.com/politics/en-larry-romanoff-the-us-healthcare-system-october-20-2020/

    The US Healthcare System

    美国医疗体系

    (4) https://www.reuters.com/article/us-heart-risk-heartburn-drugs-idUSKBN0OQ2DI20150610

    Some heartburn drugs may carry heightened risk of heart attack

    一些胃灼热药物可能会增加心脏病发作的风险

    (5) https://www.nbcnews.com/news/investigations/people-keep-falling-sick-how-poor-indians-are-recruited-clinical-flna293239

    ‘People keep falling sick’: How poor Indians are recruited for clinical drug trials

    们不断生病贫穷的印度人如何被招募参加临床药物试验

    (6) https://www.kenallenlaw.com/2012/03/dateline-nbc-hansen-expose-of-fda-drug-testing-overseas-drug-trials-arent-trustworthy-which-means-maybe-your-prescription-drugs-arent-either/

    Dateline NBC Hansen Expose of FDA Drug Testing: Overseas Drug Trials Aren’t Trustworthy Which Means Maybe Your Prescription Drugs Aren’t Either

    NBC汉森揭露FDA药物测试:海外药物试验不可信,这意味着你的处方药也不可信

    (7) https://www.aljazeera.com/program/fault-lines/2011/7/11/outsourced-clinical-trials-overseas/

    Outsourced: Clinical trials overseas

    外包:海外临床试验

    (8) https://www.forbes.com/2010/05/12/health-care-drugs-medical-opinions-contributors-henry-miller-gregory-conko.html

    Off Target On Off-Label Drugs – Forbes

    标签药物的非目标福布斯

    Copyright © Larry RomanoffBlue Moon of ShanghaiMoon of Shanghai, 2022

    权所有(拉里·罗曼诺夫上海的蓝月亮上海之月, 2022