A Litany of Pharma Crimes – Part 3 – Side Effects & Trials
By Larry Romanoff, March 10, 2022
Part 1, Part 2, Part 3, Part 4
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.
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.
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)
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.
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".
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."
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.
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.
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.
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.
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:
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.”
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?
Clinical Trials of Pharmaceuticals
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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:
“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."
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.
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.
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.
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.
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.
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.
Note to Readers: The above-referenced articles and quotations by Peddicord, Rogers, Anderson et al, appear to have been scrubbed from the internet.
Off-Label Promotion
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:
“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.
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
Next: Part 4 –US Pharma in China
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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).
His full archive can be seen at https://www.bluemoonofshanghai.com/ + https://www.moonofshanghai.com/
He can be contacted at: 2186604556@qq.com
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NOTES
Notes Pharma Part 3
(1) https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2898%2923016-9/fulltext
Adverse drug reactions remain a major cause of death
ADVERSE DRUG REACTIONS: A Leading Cause Of Death
The US Healthcare System
(4) https://www.reuters.com/article/us-heart-risk-heartburn-drugs-idUSKBN0OQ2DI20150610
Some heartburn drugs may carry heightened risk of heart attack
'People keep falling sick': How poor Indians are recruited for clinical drug trials
Dateline NBC Hansen Expose of FDA Drug Testing: Overseas Drug Trials Aren’t Trustworthy Which Means Maybe Your Prescription Drugs Aren’t Either
(7) https://www.aljazeera.com/program/fault-lines/2011/7/11/outsourced-clinical-trials-overseas/
Outsourced: Clinical trials overseas
Off Target On Off-Label Drugs - Forbes
Copyright © Larry Romanoff, Blue Moon of Shanghai, Moon of Shanghai, 2022
