Breaking down the dirty of specific pharma companies: #4 Glaxo-Smith-Kline

This company is now known as GSK.  They are an England based company who are well known as the legacy pharmaceutical company who created Amoxicillin.  They are in the psychiatry realm with drugs such as Wellbutrin, Paxil, and anti-nausea medications like Zofran.  We are highlighting GSK today because of their DEPLORABLE history of shady deceptive practices. 

They have an extensive list of controversy.  In 2010, the US Department of Justice announced that GSK would pay a US$150 million criminal fine and forfeiture, and a civil settlement of US$600 million under the False Claims Act. The fines stemmed from production of improperly made and adulterated drugs from 2001 to 2005, at GSK's subsidiary, SB Pharmco Puerto Rico Inc. The drugs involved were Kytril, an antiemetic; Bactroban, used to treat skin infections; Paxil, the anti-depressant; and Avandamet, a diabetes drug.The case began in 2002, when GSK sent experts to fix problems cited by the FDA. The lead inspector recommended recalls of defective products, but they were not authorized; she was fired in 2003, and filed a whistleblower lawsuit. In 2005, federal marshals seized US$2 billion worth of products, the largest such seizure in history.

The Pandemrix influenza vaccine was developed by GlaxoSmithKlinefIn in 2006. It was used by Finland and Sweden in the H1N1 mass vaccination of the population against the 2009 swine flu pandemic. In August 2010, The Swedish Medical Products Agency (MPA) and The Finnish National Institute for Health and Welfare (THL) launched investigations regarding the development of narcolepsy as a possible side effect to Pandemrix flu vaccination in children, and found a 6.6-fold increased risk among children and youths, resulting in 3.6 additional cases of narcolepsy per 100,000 vaccinated subjects.

In February 2011, The Finnish National Institute for Health and Welfare (THL) concluded that there is a clear connection between the Pandemrix vaccination campaign of 2009 and 2010 and the narcolepsy epidemic in Finland. A total of 152 cases of narcolepsy were found in Finland during 2009–2010, and ninety percent of them had received the Pandemrix vaccination.

In July 2012, GSK pleaded guilty in the United States to criminal charges, and agreed to pay US$3 billion, in what was the largest settlement until then between the Justice Department and a drug company. The US$3 billion included a criminal fine of $1 billion, and the remaining US$2 billion covered a civil settlement with the government under the False Claims Act. The investigation was launched largely on the basis of information from four whistleblowers who filed qui tam (whistleblower) lawsuits against the company under the False Claims Act. The charges stemmed from GSK's promotion of the anti-depressants Paxil (paroxetine) and Wellbutrin (bupropion) for unapproved uses from 1998 to 2003, specifically as suitable for patients under the age of 18, and from its failure to report safety data about Avandia (rosiglitazone), both in violation of the Federal Food, Drug, and Cosmetic Act. Other drugs promoted for unapproved uses were two inhalers, Advair (fluticasone/salmeterol) and Flovent (fluticasone propionate), as well as Zofran (ondansetron), Imitrex (sumatriptan), Lotronex (alosetron) and Valtrex (valaciclovir). The settlement also covered reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program, and kickbacks to physicians to prescribe GSK's drugs. There were all-expenses-paid spa treatments and hunting trips for doctors and their spouses, speakers' fees at conferences, and payment for articles ghostwritten by the company and placed by physicians in medical journals. The company set up a ghostwriting program called CASPPER, initially to produce articles about Paxil but which was extended to cover Avandia.

GSK was fined for promoting Paxil (paroxetine) for treating depression in the under-18s, although the drug had not been approved for pediatric use.^[9] Paxil had US$4.97 billion worldwide sales in 2003. The company conducted nine clinical trials between 1994, and 2002, none of which showed that Paxil helped children with depression.^[153] From 1998, to 2003, it promoted the drug for the under-18s, paying physicians to go on all-expenses paid trips, five-star hotels and spas. From 2004, Paxil's label, along with those of similar drugs, included an FDA-mandated boxed warning that it might increase the risk of suicidal ideation and behaviour in patients under 18.  An internal SmithKline Beecham document said in 1998, about withheld data from two GSK studies: "It would be commercially unacceptable to include a statement that [pediatric] efficacy had not been demonstrated, as this would undermine the profile of paroxetine." The company ghostwrote an article, published in 2001, in the Journal of the American Academy of Child and Adolescent Psychiatry, that misreported the results of one of its clinical trials, Study 329. The article concluded that Paxil was "generally well tolerated and effective for major depression in adolescents." The suppression of the research findings is the subject of the 2008 book Side Effects by Alison Bass. 

For 10 years GSK marketed Paxil as non-habit forming. In 2001, 35 patients filed a class-action suit alleging they had had withdrawal symptoms, and in 2002, a Los Angeles court issued an injunction preventing GSK from advertising that the drug was not habit forming. The court withdrew the injunction after the FDA objected that the court had no jurisdiction over drug marketing that the FDA had approved.^[160] In 2003, a World Health Organization committee reported that Paxil was among the top 30 drugs, and top three antidepressants, for which dependence had been reported.  

The company was also fined for promoting Wellbutrin (bupropion) – approved at the time for major depressive disorder and also sold as a smoking-cessation aid, Zyban – for weight loss and the treatment of attention deficit hyperactivity disorder, sexual dysfunction and substance addiction. GSK paid doctors to promote these off-label uses, and set up supposedly independent advisory boards and Continuing Medical Education programs.  Italian police sought bribery charges in May 2004, against 4,400 doctors and 273 GSK employees. GSK and its predecessor were accused of having spent £152m on physicians, pharmacists and others, giving them cameras, computers, holidays and cash. Doctors were alleged to have received cash based on the number of patients they treated with a cancer drug, topotecan (Hycamtin). In 2006, in the United States GSK settled the largest tax dispute in IRS history, agreeing to pay US$3.1 billion. At issue were Zantac and other products sold in 1989–2005. The case revolved around intracompany transfer pricing—determining the share of profit attributable to the US subsidiaries of GSK and subject to tax by the IRS.

As you can see…..they are no stranger to bullshit and shenanigans.  Their history of shady stuff is one of the worst.  

Their covid involvement: remember, they are part of the Covid Alliance squad.  

In July 2020, the UK government signed up for 60 million doses of a COVID-19 vaccine developed by GSK and Sanofi. It uses a recombinant protein-based technology from Sanofi and GSK's pandemic technology. The companies claimed to be able to produce one billion doses, subject to successful trials and regulatory approval, during the first half of 2021.^[97] The company also agreed to a $2.1 billion deal with the United States to produce 100 million doses of the vaccine. (I have not seen their product come to market in the US). 

In October 2020, GSK told some staff that while at work they should disable the contact tracing function of the NHS test-and-trace app which monitors the spread of COVID-19. GSK explained the reason for this was due to social distancing measures in place at their sites rendering the technology unnecessary. 

Per their website https://www.gsk.com/en-gb/media/our-response-to-covid-19/

We partnered with several companies working on vaccines by providing them with access to our adjuvant technology.Adding an adjuvant to a vaccine can improve the immune system’s response to the vaccine and may allow for more doses to be produced because a smaller amount of vaccine is needed to generate immunity.Together with Sanofi, our adjuvanted vaccine provides broad neutralising antibody responses against currently known and tested variants of the virus. This vaccine is indicated as a booster in the European Union and Great Britain. Our collaboration with SK bioscience has led to the development of an adjuvanted vaccine that is approved in South Korea. SK bioscience has submitted regulatory applications and intends to make the vaccine available through the COVAX Facility, if the necessary approvals are granted.  (Their contribution is the ADJUVANTS IN THE VACCINE).  I wonder what is in those adjuvants?  We have speculated many not great things, listed as “proprietary”.  They are focused more overseas than in the USA, but lets not forget the incidence of European soccer players collapsing over the last 18 months.  The 1,000+ athletes that have collapsed, many were vaccinated outside of the USA.  

They aren’t done yet though.  In addition to these adjuvanted vaccines, our work to develop new mRNA vaccines includes a COVID-19 R&D Alliance program with CureVac, which began clinical trials in 2022. If successful, these mRNA vaccines would protect against multiple COVID-19 variants. This agreement builds on a previously established collaboration between GSK and CureVac to develop up to five mRNA-based vaccines and monoclonal antibodies.  Ohhhh they also have a new monoclonal antibody treatment in the pipeline.  Expecting more variants, are they?  

In closing, who they are in bed with tells the story.  “To ensure our innovations reach the people who need them, we work with partners such as WHO, Gavi, CEPI, European Commission, Gates Foundation, Wellcome Trust and Save the Children. These partnerships help us to expand sustainable access and strengthen health systems. Most importantly, we work with local partners so that what we do is driven by local needs and guided by local knowledge.”  Notice that the WHO and Gates foundation are in bed with ALL the pharma companies we have discussed so far?  Not a coincidence.