From the Brownstone Institute

By  Julie Sladden 

It was one of those conversations you never forget. We were discussing – of all things – the Covid injections, and I was questioning the early ‘safe and effective’ claims put forward by the pharmaceutical industry. I felt suspicious of how quickly we had arrived at that point of seeming consensus despite a lack of long-term safety data. I do not trust the pharmaceutical industry. My colleague did not agree, and I felt my eyes widen as he said, “I don’t think they would do anything dodgy.” Clearly, my colleague had not read the medical history books. This conversation slapped me out of my own ignorance that Big Pharma’s rap sheet was well-known in the profession. It isn’t.

With this in mind, let’s take a look at the history of illegal and fraudulent dealings by players in the pharmaceutical industry; an industry that has way more power and influence than we give them credit for.

Before I continue, a word (not from our sponsor). There are many people working in this industry who have good intentions towards improving healthcare for patients, dedicating their lives to finding a cure or treatment for disease. Some therapeutic pharmaceuticals are truly life-saving. I probably wouldn’t be here today were it not for a couple of life-saving drugs (that’s a story for another time). But we must be very clear in our understanding. The pharmaceutical industry, as a whole and by its nature, is conflicted and significantly driven by the mighty dollar, rather than altruism.

There are many players and different games being played by the industry. We ignore these at our peril. The rap sheet of illegal activities is alarming. It seems that barely a month goes by without some pharmaceutical company in court, somewhere. Criminal convictions are common and fines tally into the billions. Civil cases, with their million-dollar settlements, are abundant too.

A 2020 peer-reviewed article published in the Journal of the American Medical Association outlines the extent of the problem. The group studied both the type of illegal activity and financial penalties imposed on pharma companies between the years 2003 and 2016. Of the companies studied, 85 percent (22 of 26) had received financial penalties for illegal activities with a total combined dollar value of $33 billion. The illegal activities included manufacturing and distributing adulterated drugs, misleading marketing, failure to disclose negative information about a product (i.e. significant side effects including death), bribery to foreign officials, fraudulently delaying market entry of competitors, pricing and financial violations, and kickbacks.

When expressed as a percentage of revenue, the highest penalties were awarded to Schering-Plough, GlaxoSmithKline (GSK), Allergan, and Wyeth. The biggest overall fines have been paid by GSK (almost $10 billion), Pfizer ($2.9 billion), Johnson & Johnson ($2.6 billion), and other familiar names including AstraZeneca, Novartis, Merck, Eli Lilly, Schering-Plough, Sanofi Aventis, and Wyeth. It’s quite a list, and many of the Big Pharma players are repeat offenders.

Prosecuting these companies is no mean feat. Cases often drag for years, making the avenue of justice and resolution inaccessible to all but the well-funded, persistent, and steadfast. If a case is won, pharma’s usual response is to appeal to a higher court and start the process again. One thing is clear; taking these giants to court requires nerves of steel, a willingness to surrender years of life to the task, and very deep pockets.

For every conviction, there are countless settlements, the company agreeing to pay out, but making no admission of guilt. A notable example is the S35 million settlement made, after 15 years of legal maneuvering, by Pfizer in a Nigerian case that alleged the company had experimented on 200 children without their parent’s knowledge or consent.

Reading through the case reports, the pattern of behavior is reminiscent of the movie Groundhog Day with the same games being played by different companies as if they are following some kind of unwritten playbook.

Occasionally there is a case that lifts the lid on these playbook strategies, revealing the influence of the pharma industry and the lengths they are willing to go to, to turn a profit. The Australian Federal Court case Peterson v Merck Sharpe and Dohme, involving the manufacturer of the drug Vioxx, is a perfect example.

By way of background, Vioxx (the anti-arthritis drug Rofecoxib) was alleged to have caused an increased risk of cardiovascular conditions including heart attack and stroke. It was launched in 1999 and, at peak popularity, was used by up to 80 million people worldwide, marketed as a safer alternative to traditional anti-inflammatory drugs with their troublesome gastrointestinal side effects.

In Peterson v Merck Sharpe and Dohme, the applicant – Graeme Robert Peterson – alleged the drug had caused the heart attack he suffered in 2003, leaving him significantly incapacitated. Peterson argued that the Merck companies were negligent in not having withdrawn the drug from the market earlier than they did in 2004 and, by not warning of the risks and making promotional representations to doctors, were guilty of misleading and deceptive conduct under the Commonwealth Trade Practices Act 1974.

In November 2004 Dr David Graham, then Associate Director for Science and Medicine in FDA’s Office of Drug Safety provided powerful testimony to the US Senate regarding Vioxx. According to Graham, prior to the approval of the drug, a Merck-funded study showed a seven-fold increase in heart attacks. Despite this, the drug was approved by regulatory agencies, including the FDA and the TGA.

This finding was later supported by another Merck-funded study, VIGOR – which showed a five-fold increase, the results of which were published in the high-impact New England Journal of Medicine. It was later revealed by subpoena during litigation that three heart attacks were not included in the original data submitted to the journal, a fact that at least two of the authors knew at the time. This resulted in a ‘misleading conclusion’ regarding the risk of heart attack associated with the drug.

By the time Peterson v Merck Sharpe and Dohme, an associated class action involving 1,660 people, was heard in Australia in 2009, the international parent of MSD, Merck, had already paid $4.83 billion to settle thousands of lawsuits in the US over adverse effects of Vioxx. Predictably, Merck made no admission of guilt. The Australian legal battle was a long, drawn-out affair, taking several years with more twists and turns than a cheap garden hose (you can read more about it here and here).

Long story short, a March 2010 Federal Court finding in favor of Peterson was later overturned by a full bench of the Federal Court in Oct 2011. In 2013, a settlement was reached with class action participants which resulted in a mere maximum payment of $4,629.36 per claimant. MSD generously waived their claim for legal costs against Peterson.

What’s notable in this battle was the headline-grabbing courtroom evidence detailing the extent of alleged pharmaceutical misdeeds in marketing the drug. The pharma giant went to the lengths of producing sponsored journals with renowned scientific publisher Elsevier, including a publication called The Australasian Journal of Bone and Joint Medicine. These fake ‘journals’ were made to look like independent scientific journals, but contained articles attributed to doctors that were ghostwritten by Merck employees. Some doctors listed as honorary Journal board members said they had no idea they were listed in the journal and had never been given any articles to review.

But wait, there’s more.

The trove of internal emails presented in evidence revealed a more sinister level of operation. One of the emails circulated at the pharma giant’s US headquarters contained a list of ‘problem physicians’ that the company sought to ‘neutralize’ or ‘discredit.’ The recommendations to achieve these ends included payment for presentations, research and education, financial support of private practice, and ‘strong recommendation(s) to discredit.’ Such was the extent of intimidation, that one professor wrote to the head of Merck to complain about the treatment of some of his researchers critical of the drug. The court heard how Merck had been ‘systematically playing down the side effects of Vioxx’ and their behavior ‘seriously impinge(d) on academic freedom.’

This alleged systematic intimidation was as extensive as it was effective. Result? Merck made over $2 billion per year in sales before Vioxx was finally pulled from pharmacy shelves in 2004. In his testimony, Dr Graham estimated that between 88,000 and 139,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx in the US alone before it was withdrawn.

These systems of influence, manipulation, and tactics were largely operative when Covid arrived. Add to that the ‘warp speed’ development of novel ‘vaccines,’ government green lights, pharmaceutical indemnity, and confidential contracts. Now you have the makings of a pharmaceutical payday the likes of which we have never seen before.

It should come as no surprise then, the recent announcement that five US states – Texas, Kansas, Mississippi, Louisiana, and Utah – are taking Pfizer to court for withholding information, and misleading and deceiving the public through statements made in marketing its Covid-19 injection. That these cases are filed as civil suits under consumer protection laws is likely just the tip of the pharmaceutical playbook iceberg. No doubt the discovery process will hold further lessons for us all.

Author

Julie Sladden

Dr Julie Sladden is a medical doctor and freelance writer with a passion for transparency in healthcare. Her op-eds have been published in both The Spectator Australia and The Daily Declaration. In 2022, she was elected as a Local Government Councillor for West Tamar in Tasmania.

From the Brownstone Institute

By  Cecilie Jilkova 

The UN committee approved the text of the Convention on Combating Cybercrime. Human rights organizations and information technology experts have called it a threat to democracy and the free world.

“One of the world’s most dangerous surveillance treaties was approved with a standing ovation,” wrote Austrian digital rights group Epicenter Works.

The UN General Assembly is now due to vote on the adoption of the Convention in September.

“It can be assumed that the treaty will be accepted without difficulty at the UN General Assembly in September, and will thus be officially considered a UN convention. After that, it will be available for signature and subsequently it can be ratified,” said political advisor Tanja Fachathalerová. “It can be assumed that it will not be a big problem to achieve the necessary forty ratifications, which are necessary for the treaty to enter into force.”

Legitimization of Repression against Journalists and Opponents

The proposed international treaty aims to combat cybercrime and improve international cooperation between law enforcement agencies. However, more than a hundred human and civil rights organizations around the world have warned of a serious threat to human rights and criticized the fact that the text of the treaty lacks adequate safeguards. According to them, the planned agreement would oblige UN member states to introduce comprehensive measures for the supervision of a wide range of crimes.

“The contract is really a surveillance agreement with too few provisions on data protection and human rights. In practice, it legitimizes the more repressive measures against political opponents or journalists that we now see in authoritarian states,” writes the netzpolitik.org server.

China and Russia Stood at the Beginning of the Convention

It all started with a UN resolution initiated in 2019 by Russia, China, and other countries (such as Iran, Egypt, Sudan, and Uzbekistan) with 88 votes in favor, 58 against, and 34 abstentions.

European states have proposed changes, but according to experts, the resulting compromise does not even meet the conditions necessary to preserve privacy and protect human rights.

“Unfortunately, a data access treaty has been drawn up that will allow governments around the world to exchange citizens’ personal information in perpetual secrecy in the event of any crime the two governments agree is ‘serious.’ This would include eavesdropping on location and real-time communications around the world, and force IT workers to divulge passwords or other access keys that would compromise the security of global systems that billions of people rely on every day. And it’s not just private sector systems – government systems are also at risk,” said Nick Ashton-Hart, Digital Economy Policy Director at APCO, who is also leading the Cybersecurity Tech Accord delegation to the Convention negotiations.

The Threat of Criminal Prosecution of Journalists and White Hackers

The Ashton-Hart treaty also puts journalists and whistleblowers at risk of prosecution. The International Press Institute was so concerned about this risk that it placed a full-page ad in the Washington Post. Independent security experts around the world also warned in February that they could face criminal prosecution for their work protecting IT systems from cybercriminals under the draft Convention.

Governments Could Prosecute Children for Sexting

“Incredibly, the text expressly allows governments to prosecute children for “sexting” in the same article (14) that is supposed to protect them from sexual predators. The article also puts people working in charities who help bring predators to justice at risk of prosecution because they need access to material created by predators as part of their work. Civil society advocates have repeatedly pointed out this obvious deficiency, but to no avail,” Ashton-Hart said.

Concerns about Freedom of Expression

According to experts, companies that operate internationally will also be exposed to increased legal and reputational risk after the arrest of employees. The private data of individuals and vulnerable communities can be accessed by law enforcement agencies around the world, even in cases where the perpetrators’ actions are not criminal in their place of residence or in cases that raise significant concerns about freedom of expression.

Cooperation between authorities and states can be kept secret without transparency about how governments use the treaty, or without provisions that allow companies to challenge law enforcement requests, even if they are illegal.

Criticizing Leaders as a Crime?

“Facilitating collusion in any ‘serious’ crime opens the door to ‘crimes’ such as criticizing leaders or persecuting minorities,” writes Ashton-Hart in his analysis.

On August 13, the International Chamber of Commerce, the world’s largest and most representative representative of the private sector, openly called on the UN not to adopt the convention at the General Assembly in September.

“If governments fail again to protect the international human rights legal framework they so often vociferously support, then new, dangerous norms created in international law will haunt us for decades to come,” Ashton-Hart said.

Republished from the author’s Substack