An Introduction to Big Pharma
By Larry Romanoff, February 12, 2022
Large corporations have taken over the US government to the degree that corporate crimes are now considered detached from, and contain no personal responsibility on the part of, their executives and management. In the many cases like those I have detailed elsewhere, the companies paid fines but no executives were charged, in spite of the criminality and sometimes massive death tolls. Medical crimes and legal claims had become so prevalent in America that the large pharma companies successfully lobbied the US government for immunity from prosecution for their crimes. A few years ago, the FDA - the same FDA, it should be noted, that American corporations use as a health care and food safety "quality reference" - instituted a new federal policy stating that FDA approval overrides most claims for damages against medical device makers and pharmaceutical manufacturers, giving them full protection from lawsuits. The large pharma companies successfully lobbied Congress to legislate that they are free from prosecution and any liability for flawed, debilitating or fatal medications and vaccines even if it is proven that the firms lied on their FDA applications and falsified all their test data. American consumers who experience serious health consequences from unsafe medications or faulty medical devices now have little recourse.
These people - and they are people, not corporations - are hardened sociopaths who don't cringe at high death tolls resulting from their insane pursuit of profits. It isn't only a few faked test results or a failure to notify the FDA of a drug's harmful side effects. The American pharma industry has a 100-year history of committing almost every crime imaginable short of bank robbery and arson, and I'm not sure about the arson. On the medical side we have: faked and non-existent drug tests, falsifying drug test results, falsifying manufacturing records, adulteration of medications, mis-weighing of contents, non-disclosure of harmful and fatal side-effects, non-disclosure of failed drug tests, off-label marketing, bribery, false advertising, selling adulterated drugs and defective medical appliances, illegal medical experiments.
The above are industry-specific crimes related to the manufacture and sale of vaccines and medicines, but pharma companies are also multinational corporations and share a litany of crimes and illegal behavior with their brethren in all industries. A short list: Illegal political contributions and campaign financing, political bribery, price-fixing conspiracies, illegal market share allocations, conspiracy to eliminate competition, bid-rigging, defrauding Medicare with false claims, environmental crimes, dumping of hazardous chemicals and waste, financial and securities crimes, insider stock trading, stock price manipulation, tax evasion, racketeering, obstruction of justice, witness tampering, destruction of legal records, destruction of evidence.
The Editor of the Urban Right Healthcare Weblog wrote that
"The constant march of legal settlements by, jury verdicts against, and in some cases criminal convictions of or guilty pleas by, large health care corporations indicate how common misbehavior by such organizations has become. Since it is likely that much misbehavior does not lead to publicly announced legal actions, what is published can only provide a floor for an estimate of how common it is. The march ... shows how sleazy and often corrupt health care has become, and how that sleaziness and corruption is prevalent not just among small players, but among the biggest and richest health care organizations, and their top leaders. One reason the situation continues to be so bad is that while the unethical behavior does sometimes result in pontificating by the civil authorities, and fines that may only be costs of doing business, it rarely leads to meaningful negative consequences for those who authorized, directed or implemented it."
In March of 2012, Kelly Kennedy wrote an article in USA Today that outlined the difficulties caused by weak regulation, revolving doors and heavy lobbying by the American pharmaceutical industry. It is well known that the largest US drug makers have paid many billions in fines during the past several years, but to no apparent avail in terms of eliminating, or even reducing, the systemic corruption that is so entrenched in the industry. Pfizer alone has paid billions in fines in the past few years and has been forced to sign three separate so-called 'corporate integrity agreements' meant to enforce the prevention of future fraud, but the company continued to produce new violations and in fact was initiating and perpetrating new additional frauds while negotiating financial settlements for prior frauds. You can't be more brave than that. Baxter, Merck, Johnson & Johnson, Abbott and Bristol-Meyers are the same, being repeat offenders without apparent concern. Certainly, part of their boldness stems from the total immunity of the firms' executives and officers to criminal charges, fines and prison sentences, which in turn stems from the enormous influence these firms have over members of Congress. As with most regulatory bodies in the US today, notably in the pharma, banking, defense, and securities industries, there exists a virtual revolving door between the industry being regulated and the regulator, in this case the FDA. A third side is that these firms control exclusive long-term patents on hundreds of medications that are vitally necessary to the US Health Service and the medical industry, where no suitable alternatives exist. I will deal with the details of these in subsequent chapters.
The authorities and government investigators claim they have almost no tools left with which to perform their regulatory functions, the firms' heavy lobbying of Congress having created an almost total immunity which results in only small punishments (to shareholders) for even the most egregious of crimes. The fines have proven useless in containing the criminal behavior, and the “corporate integrity” agreements are mostly just ignored. The Health Department has reached the point where they want to ban these firms forever from the Medicare supply chain, meaning they would no longer be able to supply medications for government reimbursement, an act which would cost them half their market. But the pharma companies have so much power they remain defiant even in the face of such threats, reminding the health authorities that their medications are vital to the nation and they therefore cannot be excluded. The Justice Department is now escalating this conflict with threats to cancel the firms' patents on these drugs, as a criminal punishment, and open the field to generic production to fill the nation's needs. In an attempt to create some order by closing the revolving door, Congress is considering a law prohibiting any individuals from ever working for the Federal government, if they have been involved with any pharma company that has committed fraud, but this effort is itself experiencing intensive lobbying by the firms and their powerful industry association.
In recent years, leading members of Big Pharma like GSK, Pfizer, Johnson & Johnson, AstraZeneca, Merck, Abbot, Schering-Plough, Novartis and Eli Lilly have paid about $30 billion in fines to settle charges of misleading marketing, illegal off-label promotion, bribes and kickbacks, false claims, Medicare fraud, inferior and contaminated manufacturing processes, false efficacy claims for new medications, dangerous and useless vaccines, falsifying test data, bribery and other crimes. But even a brief examination of these firms' total revenues and profits prove these apparently huge fines are merely insignificant marketing costs, and the criminal investigations merely an irritant. For example, GSK paid $3 billion in fines for criminal activity that produced about $30 billion in revenue. That's nothing more than a 10% tax. If you're a pharma company, serious crime is the best-paying job in America.
Almost every major drug maker has been accused in recent years of giving kickbacks to doctors or shortchanging federal programs. Prosecutors said that they had become so alarmed by the growing criminality in the industry that they had begun increasing fines into the billions of dollars and would more vigorously prosecute doctors as well. But as an indication of the depth and extent of the corruption in the American pharma industry, a Dr. Scott Gottlieb, a former top FDA regulatory official who is now a consultant and lobbyist for pharma companies, said (apparently without shame) that government prosecutors were increasingly criminalising "what reasonable people might argue is a reasonable exchange of important clinical information between drug companies and doctors". Bribery, kickbacks, defrauding Medicare, false advertising, off-label sales, promotions of medication for illegal and unapproved uses are now transformed into "a reasonable exchange of important clinical information". One authority stated, "The U.S. pharmaceutical industry, long one of the most profitable in the country, with profits last year of close to $50 billion, has engaged in an unprecedented amount of criminal activity in the past decade. Unfortunately, the ever-escalating fines are unlikely to stop drug companies from continuing to bribe doctors because they represent just a fraction of drug company profits and no one has gone to jail."
In late 2011, a prominent editor of a medical journal wrote that medical institutions should firmly prohibit their faculty from doing research on drugs when they are receiving lucrative speaking and consulting payments from the drug industry. He said the only solution was to rid the industry of its plethora of unethical practices, that disclosure was not sufficient to curb bad, biased and financially-corrupted science. Investigative health journalist Alison Bass wrote of the multitude of so-called "drug studies" that are secretly financed by the manufacturers themselves, that are never properly peer-reviewed, and are normally done by researchers with deep financial ties to the manufacturers of those same medications. She wrote "it's not enough to fine drug companies for deceptive and illegal marketing tactics. There has to be real reform in the medical research establishment. Until universities and doctors stop taking money that taints their scientific judgment and refrain from putting their names on papers they didn't write, how can the American public trust any health professional when it comes to the safety and effectiveness of prescribed drugs?" Her comments deserve wide support. Many so-called studies are written by employees of the pharma company or by someone paid a great deal of money by that firm. Invariably, they push the 'new, improved' and much more expensive medications that are almost never better than the lower-margin drugs they are meant to replace. And worse, most of the studies are either skewed, with the data almost always manipulated and surprisingly often completely fabricated, and they almost never inform of the many and often serious or deadly side effects. They are essentially fraudulent marketing tools, yet relied upon by physicians and the FDA.
The American practice of permitting these criminal organisations "to neither admit nor deny" the allegations and charges is itself a seriously corrupt practice that must cease. No company "agrees" to pay billions of dollars to satisfy criminal and civil charges if it's not guilty, and this charade of pretense where firms are permitted to hold press conferences and publicly state they did no wrong but settled 'to move forward', must be stopped. Guilty is guilty, and in fact the process of "settlements" - which are agreements arrived at out of court - are also corrupt and should also be stopped. Except in unusual circumstances, there should be no out-of-court settlements, with most cases going to trial.
Big Pharma is a Money Business, not a Health Business
You will recall from my articles on capitalism that American industry abandoned early on its pretense of making high-quality products, as a natural result of the new mantra of profit maximisation. When American capitalists redefined "long-term" as three months, making a product to last a lifetime became a kind of self-inflicted injury, in that if they manufactured a set of kitchen pots that would last for generations, that purchaser was lost as a customer forever. The natural corollary was that a poor-quality item would require repeated disposal and repurchase thereby guaranteeing repeat customers and higher profits indefinitely, whereupon our greed-driven captains of industry quickly embarked on a plan to continually degrade product quality and ensure the necessity of continued replacement. By the 1980s, almost all American multi-nationals and large corporations had joined the race to the bottom.
This important lesson in the economics of greed wasn't lost on the pharma companies, who realised just as quickly that producing a cure for a disease would have the same result as that from high-quality pots and pans, which is no repeat customers and the death by suicide of its own revenue stream. And that means the major pharma companies are essentially producing what I call 'pain-killer' medications, drugs which fail to address the root cause of an illness but which provide temporary relief by masking the symptoms, thereby creating hundreds of millions of drug-dependent repeat customers. More than a few pharmacists have confirmed documented reports that pharma companies mostly invest research dollars into a search for these "control medications" and their clinical trials, rather than search for actual cures for an illness. The emphasis is on managing the symptoms while maintaining the disease, very effectively utilising physicians and hospitals as front-line soldiers to convert every patient into a long-term cash stream.
I have acquaintances with some knowledge of the pharmaceutical industry who confide suspicions that discovered cures have actually been suppressed in favor of the continued production of control medications, and I have seen some documentation that provides at least circumstantial evidence to support these claims. Naturally, industry apologists are quick to dismiss these accusations as paranoid fantasies and 'conspiracy theories', but their denials appear a bit hollow and self-serving. I have seen no indisputable proof the pharma companies have shelved cures, but I harbor no doubts whatever they would do so if opportunities arose.
To counter some of the industry defenses, we need only think. There is no shortage of examples of discoveries and patents that have been shelved because they threatened someone's revenue stream, one clear example being General Motors buying and sequestering the worldwide patents for NiMH auto battery technology, an example that industry and the media still desperately want everyone to forget. In spite of all the faux moralistic outrage at such accusations, the pharma companies (and almost every large multinational) are today profit-driven to an insane degree. When GM or Ford will refuse an auto recall for a $0.90 ignition switch or a $4.00 fix for a flaming gas tank because their cost-benefit analysis proved the cost of resulting deaths to be less than that of repair, there is little point in debating the imaginary ethical standards of big business. And the claims about disease cures being potentially worth untold billions of dollars to a company and eternal fame and glory for the researcher, are just nonsense. When a country's national health service can be milked for $150,000 per year per patient for cancer treatments or AIDS medications that cost pennies to produce, fame and glory are a weak incentive to research a disease cure that would serve only to shred the income statement. No pharma company would be so stupid as to collapse its own multi-billion-dollar revenue stream for the sake of either humanity or glory.
Big pharma is in the disease business, not the cure business. A medical cure is a dead-end road that no pharma company would willingly travel. The only exceptions to this have been a few instances where epidemic-scale diseases were threatening to kill unacceptably-large numbers of the white population, as with the search for a polio vaccine. Then, the industry finds a cure. Professor John Ashton, the president of the UK Faculty of Public Health, accused the Western pharmaceutical industry of 'moral bankruptcy' for refusing to research an Ebola vaccine "because the virus only affects Africans". He wrote that the same attitude existed for decades with the scourge of AIDS because the virus was infecting and killing primarily blacks, and we had Dr. Kathy Spreen at Ranbaxy being silenced on her complaints about substandard AIDS medication in Africa on the grounds that "Who cares? It’s just blacks dying". Similarly, as I documented elsewhere, the US government for decades ignored the disease of Pellagra which was known to be caused by a simple Niacin vitamin deficiency, watching literally millions of people die needlessly, but failing to act because the deaths occurred mostly in the poverty-stricken black population. In fact, during those decades, both the authorities and the pharma companies ridiculed those deaths, referring to Pellagra as "the slave disease". Sociopathology at its finest.
There is another unpleasant aspect to this issue, being that in their frenzied pursuit of revenue streams the pharma companies have largely abandoned not only the search for cures, but any path that leads to low profit. One result is that simple medications, often arising from areas like Chinese traditional medicine, may not be patentable. This, combined with a low cost to synthesise and with a corresponding low selling price, will prevent any pursuit in this area. The pharma companies spend huge sums of money to convince physicians and the public that only patentable synthetic drugs qualify as "real medicine", and heavily discourage natural or generic sources. They also invest huge time and money to cannibalise their own medications, constantly imagining "new and improved" versions that are seldom better, often worse, almost always with increasingly more serious side effects, but that will sell at far higher prices. Drugs like Pfizer's Celebrex and Bextra, promoted as massive innovations, were nothing of the sort, specialists claiming they were no better than the old tried-and-true Ibuprofen, but sold for fifteen times as much.
A further issue is that these firms, again in their single-minded pursuit of profit, have become psychological marketers in the best tradition of Bernays and the advertising industry. One clear result is their great interest in developing what are called "lifestyle drugs", which are designer drugs for rich Americans for conditions like hair loss and sex drive maintenance, areas in which large segments of the public can be powerfully affected by clever advertising. The pharma companies being big business rather than humanitarian concerns, learned quickly there are far greater profits in the limp phalluses of rich Americans than in a malaria cure among the Malaysian poor.
Also of great concern is what we can call 'pre-emptive medicine', the increasingly long list of new medications that are not proposed as cures for medical conditions but rather as preventive measures to forestall such conditions. The theory sounds good, but the experience gained from practice is truly a cautionary tale. Merck's Vioxx was promoted as a way to prevent heart attacks in the over-65 population but instead proved to cause those same heart attacks, killing much of the population in the process. Statins today are a huge fad, excessively promoted by the pharma companies as an essentially harmless wonder drug almost mandatory to protect the world of retired people. These drugs are enormously profitable and an excellent example of pre-emptive medicine combined with lifestyle marketing, but let's not forget too quickly that Merck's Vioxx was marketed in essentially the same way, as a 'preventive' medication which in the end it most emphatically was not.
Statins are now proving to be as dangerous as Vioxx, with the pharma companies desperately trying to minimise the truly devastating side effects inherent in this range of drugs, carrying a substantial risk of severely debilitating injuries to a not inconsiderable percentage of users. They have a proven ability to destroy musculature and render previously healthy patients into almost corpses. There is no shortage of documented evidence that patients who have been prescribed statins have suffered permanent and debilitating loss of their muscle capacity, previously healthy individuals reduced to the point where they are no longer able to walk more than perhaps 50 meters without suffering uncontrollable muscle exhaustion and pain. Yet these medications have all been approved by the 'gold standard' FDA and are being heavily promoted by all pharma companies as a "necessity" for all those over age 60. The FDA once more has abandoned its prime responsibility to the public, presumably telling itself that the public can read the package warnings, competently evaluate the risks, and make an informed conscious choice. Of course, nothing could be farther from the truth.
In June of 2015 the Washington Post was aflutter with excitement about a "new and improved" class of medication that might eliminate the risk of heart attacks in America forever - statins. Of course, statins have been around for some time, long enough that the patents will soon expire and thus generating another frantic round of absolutely necessary new and improved at ten times the price. Naturally, fluttering media support is helpful in such cases. In (maybe questionable) clinical trials, these new statins appear magical, apparently producing "striking results" on cholesterol but oddly no firm opinion on whether that will actually reduce cardiac events. Nevertheless, we are assured the FDA recognises the huge unmet need for this new drug. And what is driving this huge unmet need? The profits, primarily, since this new and improved breed will cost each patient about $10,000 per year. If we multiply that by the almost 50 million US residents over age 65 - the primary victims of this new medical miracle - we get the nice round number of $500 billion dollars. What else is there to say, except to note that most of these new miracle drugs in the past 30 years have had a bad habit of causing more heart attacks than they prevented. Merck's Zocor was one of these. If you recall, the FDA did a field trial and discovered that this miracle statin not only failed to prevent cardiac arrests but in fact doubled their incidence. Vioxx was the same. But in all the excitement everybody seems to have forgotten.
And it wasn't only Zocor and Vioxx. As of early 2003, Bayer had paid well over $1 billion to settle thousands of lawsuits worldwide for deaths and severe muscle deterioration resulting from the use of the company's Baycol cerivastatin medication. Approved by the FDA in 1997 without proper testing or oversight, Baycol had to be withdrawn from the market in 2001 due to its dangerous effects. Pfizer's statin, Lipitor, was also facing a huge wave of lawsuits from injuries due to serious side effects in spite of being the best-selling prescription drug of all time, with total global sales of more than $130 billion. With more than 50 million users, Pfizer may have no shortage of lawsuits. Statins are so profitable and the FDA's approval process so reckless that pharma companies continue to produce and sell new versions even more deadly.
Health Supplements, or simple vitamins, are another category that is thriving from the massive promotional campaign carried on worldwide, again a preventive medicine taken not because its needed, but to prevent its need. I believe this is one of the greatest medical hoaxes perpetrated thus far, since excess vitamins are simply excreted by the body and are a complete waste of money. Any normal diet has always provided, and provides today, the necessary vitamin intake for good health. The few individuals suffering from vitamin deficiencies should be under the care of a physician rather than spending inordinate amounts of money on what are almost entirely useless pills. These firms are not marketing vitamins because the public needs them but simply because they are hugely profitable, in many cases costing only pennies to manufacture but selling for many tens of dollars per bottle. No person anywhere should purchase any of these items unless their physician detects a deficiency that cannot be easily remedied by other means. This vitamin industry has become so loaded with infatuation and misinformation that even a soap company like Amway is making billions of dollars selling re-manufactured pills they probably don't even understand.
Even worse, most of the 'health supplements' or vitamins offered for sale are not what they appear to be, a great many of even the best brands being nothing more than a concoction of what the industry calls "fillers", or ground up rice, wheat or soybeans with absolutely no trace of Vitamin A or Alpha-Omega or any other high-sounding health additive. Anahad O'Connor wrote a perfect article in the New York Times in November of 2013, detailing the widespread fraud existing in the health supplement market and noting that DNA tests show that many pills labled as healing herbs are nothing more than powdered rice and weeds. (1)
The industry was created in the US by American pharma companies and advertising agencies, with the benefit of large bribes to the medical profession, to the extent that Americans now spend nearly $8 billion per year on these pills to no purpose. Canadian researchers tested 44 bottles of the more popular supplements sold by many different companies and discovered that most were either heavily diluted with, or entirely replaced by, cheap fillers like soybean, wheat and rice. The findings of this study were published in the journal BMC Medicine, (2) and concur with other studies conducted elsewhere that indicate the health supplement industry is even more corrupt than its pharmaceutical big brother. There is no question the problems are widespread, the fad having been created by clever marketing that targets sincere interest in health, then hijacked by those who value money more than ethics - precisely the same situation existing in the pharma market generally.
Vaccines
Since we will soon encounter some vaccine stories, perhaps this is a suitable place to add a general note on vaccines.
"Vaccines are designed to trick your body's immune system into producing the antibodies needed to resist any future infection. However, your body is smarter than that. The artificial stimulation of your immune system produced by an attenuated or dead virus simply is not the same as your body engaging with and overcoming the real live virus." Dr. Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, wrote, "The fact that manmade vaccines cannot replicate the body's natural experience with the disease is one of the key points of contention between those who insist that mankind cannot live without mass use of multiple vaccines and those who believe that mankind's biological integrity will be severely compromised by their continued use. Is it better to protect children against infectious disease early in life through temporary immunity from a vaccine, or are they better off contracting certain contagious infections in childhood and attaining permanent immunity? Do vaccine complications ultimately cause more chronic illness and death than infectious diseases do? These questions essentially pit trust in human intervention against trust in nature and the natural order, which existed long before vaccines were created by man." Many physicians believe that "In most cases natural exposure to disease would give you a longer lasting, more robust, qualitatively superior immunity".
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 prescriptions, 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.” (3)
Side Effects
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. Pharma executives appear to perform the same kind of cost-benefit analysis as do the American auto companies, that is to compare the profits from the sales of a drug to the potential cost of deaths and lawsuits from dangerous side effects of whose existence they are already fully aware, leading inevitably to morally bankrupt marketing decisions. If Merck can make tens of billions in profit on Vioxx but pay only $4 billion in fines and penalties for the deaths it causes, that's an easy decision in terms of profit maximisation.
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. 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 Centers for Disease Control 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 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 blacks being killed by the police, "They aren't killing more blacks than before. It's just that more people have mobile phones and communicate more." The FDA made precisely the same comment, "We aren't killing more people this year than last year, but so many more people have iphones and Twitter accounts, and are telling everyone."
As I noted elsewhere, when we combine these preventable deaths from flawed medications with the large death toll from hospital errors, 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, 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. And yet nobody cares to address this, the FDA, the cowardly and 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 Prilosec, known as proton-pump inhibitors, 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. 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.
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 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 within the US 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 an overwhelming but totally unjustified faith in 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 is more fully referenced in the Chapters 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. The recruiters claim 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 losing their eyesight and the failure of internal organs, and of course there are many deaths, with most of 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 this data - both domestic and foreign - are faked.
As part of their investigation, NBC News created a fake pharmaceutical company and sent some of their correspondents to India to investigate 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 that 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 called Ken Getz, 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. 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 trials 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 fewer are willing to take 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. 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."
That's a cute story. Too bad it's not true. First, 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". Is that cool, or what? A second income. 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 removed from the internet.
Pharma Pricing Strategies
In June of 2013, the London Telegraph produced an astonishingly scandalous article that served to confirm the things we've always believed about drug prices, in this case the newspaper recording conversations with drug company executives boasting like schoolboys about selling prescription drugs for many hundreds of dollars when they cost only pennies to produce. (8) Several drug companies were willing and even eager to offer discounts of 70% or more to any pharmacist or hospital willing to prescribe their medications, with the understanding these would be billed at full prices to the Health Service and to the patients. The Telegraph used undercover reporters posing as investors planning to open a large chain of retail pharmacies, and recorded their meetings with pharma executives, producing extensive proof of the collusion to manipulate drug prices to unconscionable levels, systematically overcharging the national health services in many countries by billions of dollars each year. These pharma frauds have been escalating apparently without fear or limit, in spite of the billions paid in fines. One US Attorney General said the system needed 12 years to recover $2 billion in fines from big pharma, but a few years later recovered $3 billion in only 18 months.
The pharma companies are so overcome by greed that no amount of profit is ever sufficient, with abundant evidence in categories of drugs that are vital to the preservation of life as in many cancer drugs and those used to control AIDS. Many vital cancer medications are priced at $50,000 to $100,000 per year and more, when the production costs are often only a few dollars. As a typical example, in late 2013, in response to unprecedented public protests, a large group of over 100 consumer organisations in 35 states launched a massive class action against Abbott for anti-trust violations in increasing the price of the critical anti-AIDS drug by over 500%, from $200.00 to over $1,000.00 per package. These public actions included boycotts by physicians, demonstrations at the company's annual meetings, and a general storm of public condemnation for this profiteering. Abbott stubbornly refused to reconsider its price increase, leading the US Health Service to request that Abbott be stripped of its patent and generic versions of the drug be approved for other manufacturers. Abbott, like all pharma companies, will abandon both morality and humanity if given even a slight monopoly on a life-saving medication.
Fraudulent Investment
Most national governments are eager to see an expansion of domestic R&D, and easily fall prey to research scams perpetrated by the pharma companies who promise to greatly magnify their research expenditures in a nation in exchange for longer periods of patent protection. Too many naive governments have fallen for this ruse, only to discover that the promised research never materialised, and often that the expenditures included in so-called research were little more than daily operating expenses or clinical trials for medications that had already been developed elsewhere. I am unaware of any instances where these undertakings were actually kept, and they remind me of the false promises made by so many American firms entering into JVs in China, where promises to develop and promote domestic brands proved to be plans to milk the JVs dry and kill the brands instead.
In a National Post article in October of 2014, Tom Blackwell wrote that some years ago Canada entered an agreement with the international pharma companies to greatly lengthen their patent protection in exchange for a commitment to spend 10% of all revenue on R&D. In practice, the companies in totality reneged on their commitment, with R&D being at 4% or below, and even this figure being loaded with questionable expenses. The entire process was simply a cash grab with no intent to honor the research commitment. When presented with the evidence of these breaches of contract, the pharma companies invariably blamed Canada or other governments, claiming their local divisions have grave difficulty competing internationally, and lay the blame for this condition on the same government or its regulatory system or IP protection. (9)
As Blackwell pointed out, the extension of these drug monopolies not only delays entry of much-cheaper generics, but actually makes it harder for small domestic pharma companies to innovate, as their work often stems from existing medicines that are off patent. In all research, there is also the matter of the extreme emphasis on profit and marketability, driven by the business schools and large capitalists, which in the end will destroy the entire idea of scientific research and twist research facilities into mis-shapen profit incubators bereft of any thought of benefit to humanity or society generally. It is also true that this insane and greed-driven push to maximise profits will almost assuredly serve to prevent truly useful medical discoveries since profits arise from controlling a disease rather than from curing it. It is only within the confines of truly non-profit and totally corporate-independent facilities that socially beneficial research will be conducted.
The secret non-elected government of the European Community organised a well-thought-out plan to benefit their own European pharma companies by what was presented as an advanced method of encouraging pharmacological research for the good of the world. Their newly-created "Innovative Medicines Initiative", (10) which was to be "an alliance of corporations and universities" with the aim of developing new medications, a program with billions in funding - all drawn from taxpayer money, of course. The stated goal was to encourage innovation in the creation of essential medicines through funding universities and small research companies. But this great initiative has been a complete disaster for everyone but the pharma companies for whom it was designed. Through this program, the EU has siphoned off literally billions of dollars which have almost entirely disappeared into the coffers of the large European pharma companies - which are owned by the same individuals in the EU government who crafted this scheme. The German newspaper der Spiegel did an excellent review of this matter, demonstrating that the billions of dollars of taxpayer money have been spent almost exclusively as a tax-free subsidy to the pharma industry.
Auto companies do the same thing, promising to build factories, expand production, create new jobs, but invariably fail to adhere to the promises, often doing the opposite of cutting jobs and closing factories. And in every case I have investigated, these contracts have never contained any penalty clauses for failing to meet the commitments, meaning that local governments saddled their population with many extra years of much higher drug prices, and received nothing of benefit in exchange. These agreements have almost always been a one-sided hoax.
Additional Reading
https://www.omsj.org/corruption/scale-of-pharma-criminal-fraud-settlements-exposed
Scale of Pharma Criminal Cases Exposed
https://www.enjuris.com/blog/resources/largest-pharmaceutical-settlements-lawsuits/
10 Biggest Pharmaceutical Settlements in History
https://en.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements
List of largest pharmaceutical settlements
https://projects.propublica.org/graphics/bigpharma
Big Pharma’s Big Fines
https://www.theguardian.com/commentisfree/2022/feb/08/big-pharma-global-vaccine-rollout-covid-pfizer
Putting big pharma in charge of global vaccine rollout was a big mistake
https://www.uspharmacist.com/article/new-fda-strategy-criminal-charges-against-pharma-executives
New FDA Strategy: Criminal Charges Against Pharma Executives
https://www.huffpost.com/entry/holding-big-pharma-accoun_b_8280952
Holding Big Pharma Accountable: Why Suing The Pharmaceutical Industry Isn't Working
https://www.omsj.org/2010/19%20Billion%20pharma.pdf
Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010
Institutional Corruption of Pharmaceuticals and the Myth of Safe and Effective Drugs; An Epidemic of Harmful Side Effects
*
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.moonofshanghai.com/ and http://www.bluemoonofshanghai.com/
He can be contacted at: 2186604556@qq.com
Notes
(1) https://www.nytimes.com/2013/11/05/science/herbal-supplements-are-often-not-what-they-seem.html
Herbal Supplements Are Often Not What They Seem
(2) https://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-11-222
DNA barcoding detects contamination and substitution in North American herbal products
Off Target On Off-Label Drugs - Forbes
(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
Pharmaceutical scandal: firms boast of profits on drugs that cost 'pennies’
Drug companies well short of research spending they promised in exchange for longer patent protection
Innovative medicines initiative
Copyright © Larry Romanoff, Moon of Shanghai, Blue Moon of Shanghai, 2022
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