The GSK Covid Vaccine: Will We Be Safe?

Media reports suggest GSK, the British based pharmaceutical giant, are close to producing 1 billion doses of a coronavirus vaccine booster in 2021. Little is known about the ingredients of the vaccine, at least in the mainstream media.

GSK have merged with the French multinational pharmaceutical company, Sanofi.

Between them, GSK and Sanofi have paid out $5,063,939,512 in violation fines, GSK paying $4,422,266,058 (billion) whilst Sanofi come in at $641,673,454 (million)

GSK, who rolled out the Pandemrix vaccine for the last global pandemic, are set to make a pretty penny if they and Sanofi can get the coronavirus vaccine booster past the regulators - this process has been made easier for them due to global drug regulators giving drug companies a rapid path by allowing them to bypass animal testing.

Animal tests are a critical step in vaccine and drug development. Normally, a new vaccine can take anything between 5 to 20 years to develop before it can be made available to the public. Animal tests are carried out to determine safety and efficacy at preventing the disease in question. Regulators, such as the MHRA in the UK and the FDA in the US, usually require that a manufacturer shows a product is safe in animals before it goes into people. 

This from the European Medicines Agency:

"The regulatory workshop was held virtually on 18 March 2020 in the context of the ongoing COVID-19 pandemic. It brought together delegates from 17 different countries, representing more than 20 medicines regulatory authorities globally, as well as experts from the World Health Organization and the European Commission, to share their views on the development of vaccines against COVID-19. The meeting was co-chaired by EMA and the US Food and Drug Administration (FDA)."

The summary report of that meeting can be found here.

Pandemrix: The Swine Flu Vaccine

Research published in the BMJ in 2013 suggested a possible link between the swine flu vaccine given to children in the UK and Europe during the epidemic in 2009 and 2010 and a rare condition called narcolepsy, which causes people to fall asleep suddenly without any warning and at any time of the day.

A further report, also published in the BMJ in 2018, asked the question, 'Pandemrix vaccine: why was the public not told of early warning signs?'

In 2019, an Irish woman, Aoife Bennett, 27, who received the Pandemrix vaccine in school in 2009 as part of a state campaign against swine flu. sued the government after developing narcolepsy shortly after receiving GSK's Pandemrix. The case was settled for an undisclosed amount of compensation to the victim.

This from The Guardian:

"Bennett told RTE on Wednesday that she was active and athletic until being vaccinated in December 2009. About two weeks later the side-effects began, she said. “Things changed very drastically.” She felt “like a sloth” and became fatigued, disoriented and prone to collapse.

"She expressed dismay that it took seven years of legal proceedings to obtain compensation.

"The defendants in the case were GlaxoSmithKline Biologicals, the health service executive, the minister for health and the health products regulatory authority, formerly the Irish medicines board."

Further, in 2017, the UK high court rejected a British government appeal to withhold payments to dozens of British children who developed the sleeping disorder after swine flu vaccines. Six million people in Britain, and more across Europe, were given the Pandemrix vaccine made by GlaxoSmithKline during the 2009-10 swine flu pandemic, but the jab was withdrawn after doctors noticed a sharp rise in narcolepsy among those receiving it.

It all seems pretty clear then that GSK's Pandemrix vaccine caused narcolepsy in some who were administered it. A way to keep such news at bay is to make settlements with those who file lawsuits.

When we look into the Swine Flu pandemic, we can see similarities into what is panning out today in 2020. The same questions should be asked about the safety of any potential Covid-19 vaccine and we shouldn't have to wait until people suffer a severe adverse reaction to it as we did with the GSK's swine flu vaccine.

Incidentally, what do GSK have to say about their product, Pandemrix, causing narcolepsy? Well, only yesterday, in efforts to convince the public that there will be no problem with their new vaccine for Covid, they claimed its previous flu pandemic vaccine, (Pandemrix) which used some of the same ingredients as Covid-19 vaccines currently under development, was not linked to a rise in cases of the sleep disorder narcolepsy. 

This from RTE:

"A spokesman for GSK said the "science has moved on" since concerns were raised about links between narcolepsy and its H1N1 vaccine, called Pandemrix, which was developed during the flu pandemic 10 years ago. 

"He said evidence now suggests the link is to the H1N1 flu virus itself, not the vaccine. 

"In a statement to Reuters, the company said available scientific data suggest that "the rare occurrence of narcolepsy during the 2009/10 flu pandemic was triggered by the body confusing a protein in the wild type H1N1 flu virus with a human protein relevant in regulating the sleep cycle." 

In 2010, The Daily Mail, a British newspaper, reported on how Drug firms cashed in on scare over swine flu. Dr Wolfgang Wodarg, who at the time was head of health at the Council of Europe, branded the swine flu pandemic as 'one of the greatest medical scandals of the century.'

The 2010 Daily Mail article, which is like a version of Groundhog day playing out, also highlights how Sir Roy Anderson, a scientist who advised the UK Government on swine flu outbreak, held  a £116,000-a-year post on the board of GlaxoSmithKline.

One of the current Covid scientific advisers to the UK government, Patrick Vallance, is the former head of GlaxoSmithKline's vaccine division.

Déjà vu anyone?

Finally, although I cannot prove the authenticity of the claims in  a video that was recently uploaded to YouTube,  an independent journalist claims he has recently been contacted by a GSK whistleblower who  told him vaccines trialled out on women contained an antigen that was shown to cause a 97% increase in infertility. The antigen also allegedly makes men sterile.

The video has since been removed by YouTube but can still be accessed here.

Bob Fiddaman

Business as Usual Means Bad News for Consumers

As an advocate for drug safety, I sometimes feel as if I'm pissing in the wind. Today is one of those times. (For American readers, the Cambridge Dictionary describes pissing in the wind as "trying to do something when there is no hope of succeeding.")

This week President Trump nominated Alex Azar as the next Secretary of the Department of Health and Human Services (HHS). Azar is former senior vice president of corporate affairs and communication for US pharmaceutical giant Eli Lilly. This US announcement comes on the heels of similar incestuous behavior by the UK government which recently announced Andrew Witty, former head of GlaxoSmithKline, has been selected to head its new pathway, 'Accelerated Access Review' (AAR). Days later, GSK's website highlighted another kick in the teeth for British drug consumers: Patrick Vallance, who is currently GSK's president of research and development, will become the UK government's new Chief Scientific Adviser.

What a sick few weeks for health consumers. Three top executives from Big Pharma land positions that are supposed to better protect health consumers by ensuring scientific information is accurate, and drugs are safe and effective. These three appointments should prompt Britain and US residents to take notice and be on full DEFCON alert. I'm certain families across the globe who have lost loved ones to Prozac and Paxil won't be jumping for joy at this week's announcements, and I imagine their dead relatives are turning in their graves.

Lilly & GSK are two companies that have frequently been sued by consumers who were harmed by their dangerous products. Further, both companies have engaged in abhorrent and illegal tactics to peddle their pills. Some of these unscrupulous behaviors include paying doctors to prescribe, bribing government officials, and fraudulently marketing drugs for unapproved uses. But apparently, this type of leadership is rewarded by governments that prefer corporate collusion to consumer care.

GSK and Lilly have paid billions in fines and lawsuits because their illegal activities caused the suffering and deaths of countless innocent men, women, and children. In 2009, Lilly was fined $1.42 billion to resolve a government investigation regarding off-label promotion of the antipsychotic Zyprexa. Zyprexa had been approved for the treatment of certain psychotic disorders, but Lilly admitted to promoting the drug in elderly populations to treat dementia. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and “trained its sales force to disregard the law."

Similarly, in 2012, GSK agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs and its failure to report safety data. This is the largest healthcare fraud settlement in the United States to date. The company pled guilty to misbranding the drug Paxil for treating depression in patients under 18, even though the drug was not approved for children. GSK also pled guilty to failing to disclose safety information to the FDA about the diabetes drug Avandia. These pharmaceutical companies don't mind paying a couple of billion dollars here and there for criminal violations because shady criminal behavior reaps more sales profits than does subsequent fines. This unethical behavior is just part of pharma's business plan.

Back to Those Incestuous Appointments

Alex Azar has had previous connections to the US government. He was deputy secretary of Health and Human Services under George W. Bush and served as the chief operating officer for two years. In that role, Azar oversaw such agencies as the Food and Drug Administration (FDA), the National Institutes of Health, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services. In May 2007, Azar became senior vice president of corporate affairs and communication for Lilly. This revolving door employment agency is standard US practice. Corporate execs leave the industry for cushy jobs in government, then they leave government for industry and lobbying jobs, etc.

This incestuous fox guarding the hen house is commonplace and will continue to put consumers at great risk. It was US President George W. Bush who named Eli Lilly President and CEO, Sidney Taurel, as a Homeland Security Advisory Council member in 2002. Further, soon after the Homeland Security Act was signed in 2002, New York Times columnist Bob Herbert discovered what had been slipped into the Act at the last minute. On November 25, 2002, he wrote, “Buried in this massive bill, snuck into it in the dark of night by persons unknown…was a provision that incredibly will protect Eli Lilly and a few other big pharmaceutical outfits from lawsuits by parents who believe their children were harmed by thimerosal.” (Thimerosal is a mercury-based preservative that is used in vaccines. It was developed by Lilly in the 1920s and by the 1990s its use was widespread)

In 2003, Bush appointed Taurel to the President’s Export Council. The same year, “60 Minutes II” aired a segment on Lillygate and Prozac. Lilly's patent for Prozac had run out so they began marketing a new drug, Prozac Weekly. According to 60 Minutes II, Lilly sales reps gained access to “confidential” patient information records and mailed out free samples of Prozac Weekly. Regulations, proposed under Bill Clinton and later implemented under George Bush, contained a provision that allowed healthcare providers the right to sell a person’s confidential medical information to marketing firms and drug companies.

Bush was later rewarded for his job placements and overseeing provisions when he left the White House. He went straight to Eli Lilly headquarters where he served as an Eli Lilly Board of Director.

You scratch my back, I'll scratch yours, huh?

Assuming he's confirmed, Azar will oversee 11 agencies including the FDA, Center for Disease Control (CDC), National Institutes of Health (NIH), Administration for Children and Families (ACF) and Centers for Medicare & Medicaid Services (CMS).

When Patrick Vallance of GSK takes over the role of UK Government Chief Scientific Adviser, he will oversee science and technology-related activities and recommend policies to the Prime Minister and  Cabinet. He will also sit as chair of the UK’s Scientific Advisory Group for Emergencies.

Witty's new title is self-explanatory. He will head a new UK government initiative known as 'Accelerated Access Review' (AAR) where his role is to get new drugs and devices on the market quickly.

If you want to know more about how Lilly operates, I highly recommend John Cornwell's book, "The Power to Harm: Mind, Medicine, and Murder on Trial." It's a jaw-dropping insight regarding how far Lilly went to cover up the deadly ADRs caused by their lucrative drug, Prozac. If you want to know how GSK operate, well, there are more than 2,000 posts about GSK's shenanigans on my blog alone.

Unreported Terror & Risk

These appointments are scary and put citizens at greater risk of being harmed by unsafe, ineffective drugs, many of which should never have been approved. In both the UK and the US, we see frequent media reports about terrorist threats and acts, but we almost never hear news about pharma created deaths. When was the last time you heard a news report or read an article highlighting that prescription drugs are the fourth leading cause of death? In America, I chalk this up to the lucrative drug advertisements that essentially pay for TV news production. In the UK we don't have drug ads, but we still have pharma money negatively influencing government policy and political appointments.

Hiring CEO's of criminal corporations to protect citizens is wrong. But these types of crimes pay. If you don't like the status quo, you can petition your respective government and share your disgust. I'm sure they'll be happy to send you a form letter response within 30 days...

So, back to pissing in the wind: It's understandable I'm disgusted by this week's news. It's easy to throw up my hands when hearing such outrageous appointments. But sometimes those who've lost a loved one to pharma help me persevere. As one mom whose child died from pharma products recently said, "To the world, my child was just one person, but to me, she was the world. If my advocacy saves even one child, I have saved someone else's world."

In other news involving incestuous revolving doors, the FDA has now approved a new "digital pill." The pill contains a sensor that digitally tracks whether or not patients have ingested their medication. And what pill has this sensor been embedded into? ~ aripiprazole, (Abilify) a drug used to treat multiple mental mood disorders, including bipolar disorder and schizophrenia.

On top of this, the commissioner of the FDA, Scott Gottlieb, is opposing a natural plant, Kratom, (mitragyna speciosa) that could help people effectively treat an addiction caused by opioids.

More on the aripiprazole and kratom scandals next week.

Bob Fiddaman