Novartis: a criminal enterprise

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Swiss pharmaceutical company Novartis is among the 10 largest pharmaceutical corporations in the world, with $49.1bn in revenue in 2017. It was formed in 1996 through a merger of Swiss companies Ciba-Geigy and Sandoz. Pressured by the global financial crisis, generic competition, looming expiration of patents and dried up drug revenue pipelines, Novartis has become a criminal enterprise, its operations spanning the world.

NHS

Both Novartis and Bayer have threatened to take 12 CCGs (clinical commissioning groups) across northeast England and Cumbria to court over a new policy to offer a choice of drugs to patients with wet age-related macular degeneration (AMD), a leading cause of blindness in the elderly. The CCGs are facing judicial review for planning to offer Avastin, which is not licensed for wet AMD, alongside Lucentis and Eylea (manufactured by Bayer). Avastin and Lucentis are manufactured by Roche subsidiary Genentech, but marketed outside the US by Novartis. Novartis owns 33% of Roche. All three drugs are approved by the National Institute for Health and Clinical Excellence (NICE) for treating the condition in the NHS, and many independent retina specialists say Avastin is as clinically effective as licensed drugs as Lucentis and Eylea, but is far cheaper. This policy will save the CCGs up to £13.5 million over the next five years.

NHS patients who receive a new diagnosis of wet AMD will be told that Avastin is the preferred choice. Avastin costs £12 compared with £742 for Lucentis and £816 for Eylea. Avastin, developed for cancer but used off-label around the world, including in parts of Europe and in the US, generates lower profits for the drug companies, who claim that the CCGs are using ‘unlicensed medicines’ instead of a licensed and NICE approved option, ‘in breach of professional obligations’, and they have raised safety concerns with the intravitreal use of Avastin.

Greece

Between 2006 and 2015, as Greece fell into a deep economic crisis and forced by the Troika (EU, ECB and IMF) to cut public spending, Novartis bribed thousands of doctors and civil servants, as well as politicians and journalists (who acted as go-betweens) with about €50m to inflate and fix drug prices, boost sales of its drugs and otherwise help Novartis dominate the Greek market, according to Justice Minister Stavros Kontonis. Implicated are eight former ministers, as well as the head of the 2012 caretaker government, Panayiotis Pikrammenos, ex-Prime Minister Antonis Samaras and his 2012-2014 finance minister, ex-Bank of Greece Governor, Yannis Stournaras.

Greece’s health and social solidarity minister (2006-2009) and current EU migration commissioner Dimitris Avramopoulos took €40m in exchange for ordering ‘a huge amount’ of Novartis products, whilst his replacement in 2010, PASOK’s Andreas Loverdos, accepted €120,000 from Novartis laundered through a computer hardware firm. Stournaras received €1m via his wife’s PR company which organised congresses sponsored by Novartis. Vice president of the main opposition New Democracy, and health minister from 2013-2014, Adonis Georgiadis was also named. The vice president of Novartis Greece, Konstantinos Frouzis, transferred the money to the accounts of the officials. In return the Prime Minister fixed the prices of medicines purchased by Greece even when cheaper alternatives were available.

20 witnesses including three former Novartis employees have testified to the Supreme Court Prosecution Office. In February, the Greek parliament voted to set up a preliminary commission of inquiry to recommend prosecution, after which parliamentary immunity from prosecution can be lifted. Novartis’ crimes alone are estimated to have cost the Greek state €3bn. Overall, the illegal practices of pharmaceutical companies since 2000 has cost an estimated €23bn. Drug purchases as a fraction of total health spending in Greece increased from 23.6% in 2006 to 30.7% in 2011. Novartis denies any wrongdoing and pointed out that no indictments have been forthcoming from the corrupt Greek government.

Italy

In March 2014, the Italian Competition Authority fined Novartis and Roche over €180m for cartelising the sales of Avastin (cost €81) and Lucentis (€900). From 2011, Novartis and Roche colluded to create an artificial product differentiation and ‘purport Avastin as more dangerous than Lucentis, in order to influence prescriptions of doctors and health services’ and boost the commercial success of Lucentis. Novartis and Roche spread misleading information about risks connected to Avastin, resulting in additional costs for Italy’s national health service of about €45m in 2012 alone. In January 2018, the EU Court of Justice backed Italy’s decision.

Repeat offender

Novartis Greece’s actions form a pattern of criminality, based on their operations in other countries and the information coming from whistleblowers:

  • 2005-2013: Novartis gave bribes or ‘rebates’ to 20 US pharmacies to get them to switch kidney transplant patients from cheaper generics or Roche’s Cellcept to its immunosuppressant Myfortic.
  • 2006-2012: Novartis provided patient referrals and rebates to three specialty pharmacies BioScrip, Bioservices and Accredo so they would pressure patients to order refills of its iron-chelation drug Exjade. In October 2015, Novartis was fined $390m by the US DoJ.
  • Novartis offered kickbacks to doctors ($9.5m in 2007) to increase prescriptions of six of its drugs, and in 2010 paid $422.5m in fines for violating the False Claims Act. Doctors were targeted based on potential prescription-writing volume.
  • 2001-2011: Novartis paid ‘tens of thousands of [US] doctors kickbacks’ (over $65m) to prescribe Novartis drugs, violating the Anti-Kickback Statute.
  • 2009: Novartis and its generics business Sandoz bribed Chinese doctors to boost prescriptions of its drugs. In 2016, it paid $25m in fines to the US Securities and Exchange Commission (SEC). Novartis’ Alcon eyecare unit paid Chinese doctors in 200 hospitals for working on fabricated, non-existent post-marketing clinical trials.
  • 2014: Novartis Japan employees falsified to clinical trial data to promote hypertension drug Diovan. The Japanese government suspended Novartis' operations in the country for 15 days in 2015.
  • February 2016: Novartis’ Korea ‘handed out money and other kickbacks to local doctors’ to boost sales.
  • February 2017: Novartis, Abbot and two domestic Indian companies colluded to keep prices of Vildagliptin, a Novartis anti-diabetic drug, at artificial levels. Novartis controlled the pricing structure. India has a large burden (7.8% of adults) of diabetes.
  • June 2016: Novartis tried to stop Colombia from exercising its legal right to make a Novartis myeloid leukemia drug, Glivec affordable. The drug was priced at $15,000 (£11,000), almost twice the average income in Colombia ($8,000). US trade representative, Robert Lighthizer, wrote to the Colombian government to express ‘dissatisfaction’ with its policies on access to medicines.

 

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