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Misconduct in the Pharmaceutical Sector - AstraZeneca

AstraZeneca

My third installment on corruption in the pharmaceutical trade - AstraZeneca
Ronald Gibson

To clarify the facts below, only transgressions relating to gross ethical and legal matters are included. Civil cases are not mentioned as the outcomes are mostly based on a jury system and may be open to emotional interpretation.

This pharmaceutical giant is based in London, UK, the result of a merger between Zeneca, and Sweden’s Astra AB in 1999. This company has a vast portfolio of products in the cancer, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation fields. AstraZeneca is one of the top 5 pharmaceutical companies in the world, with manufacturing facilities in 19 countries, 9 Research and Development sites, and sales in over 100 countries with total revenue for 2016 stated as $23 Billion.

1. 2003 - Federal officials announced that AstraZeneca had pleaded guilty to criminal and civil charges relating to the illegal marketing of the prostate cancer drug Zoladex. They allowed free samples given to medical professionals to be sold to patients and claimed for from state medical insurance. The company agreed to pay $355 million, consisting of $64 million in criminal fines, a $266 million settlement of civil False Claims Act charges, and a $25 million settlement of fraud charges relating to state Medicaid programs. https://www.justice.gov/archive/opa/pr/2003/June/03_civ_371.htm

2. 2003 - Researchers at the University of Illinois-Chicago released the results of research concluding that AstraZeneca’s Seroquel and two other schizophrenia drugs made by other companies created an elevated risk for diabetes. Subsequently, more than 25,000 lawsuits were filed against the company. In 2010 the company said it would pay a total of $198 million to settle those cases. That same year, the UK’s Prescription Medicines Code of Practice Authority found that AstraZeneca had failed to adequately describe the risks of Seroquel in an advertisement for the drug in a medical journal. http://www.pharmatimes.com/news/astrazeneca_pays_out_$198_million_to_settle_seroquel_suits_982632 http://www.pharmaceutical-journal.com/news-and-analysis/news/astrazeneca-breaches-industry-marketing-code-of-practice/11001748.article

3. 2003 - The European Commission accused AstraZeneca of misusing patent rules to shield its ulcer drug Losec (Prilosec in the United States) from generic competitors. The company was charged with having misstated the year the drug was introduced in order to make it eligible for an extension of its exclusivity rights. In 2005 the commission fined AstraZeneca € 60 million, a penalty which was upheld by the European Court of Justice in 2012. http://europa.eu/rapid/press-release_MEMO-12-956_en.htm

4. 2004 - The U.S. Food and Drug Administration (FDA) found that AstraZeneca’s full-page newspaper advertisements defending the safety of its Crestor cholesterol medication were “false and misleading.” http://californiahealthline.org/morning-breakout/fda-asks-astrazeneca-to-pull-crestor-ad-because-of-misleading-claims-about-drugs-safety/

5. 2007 - A federal judge ruled in a national class action case that AstraZeneca had to pay damages in connection with overcharging Medicare and private insurance companies. The judge singled out AstraZeneca for acting “unfairly and deceptively” in its pricing of prostate cancer drug Zoladex. AstraZeneca was later hit with a $12.9 million penalty. http://www.nytimes.com/2007/06/22/business/22Drug.html

6. 2009 - AstraZeneca was one of four drug companies that entered into a settlement agreement under which they agreed to pay a total of $124 million to settle charges that they violated the federal False Claims Act by failing to provide required rebates to state Medicaid programs. AstraZeneca’s share of the total settlement amount was $2.6 million. https://www.justice.gov/opa/pr/four-pharmaceutical-companies-pay-124-million-submission-false-claims-medicaid

7. 2010 - AstraZeneca agreed to pay $103 million to settle a national lawsuit accusing the company of overcharging for Zoladex cancer drug and Pulmicort Respules asthma medication. https://www.firstwordpharma.com/node/669044?tsid=17

8. 2010 - The U.S. Justice Department announced that AstraZeneca would pay $520 million to resolve allegations that it illegally marketed its anti-psychotic drug Seroquel for uses not approved as safe and effective by the FDA. Among other things, the company was accused of having paid doctors to give speeches and publish articles (ghost-written by the company) promoting those unapproved uses. Part of the settlement was that AstraZeneca had to sign a corporate integrity agreement regarding its future behaviour. https://www.justice.gov/opa/pr/pharmaceutical-giant-astrazeneca-pay-520-million-label-drug-marketing, https://www.justice.gov/sites/default/files/usao-edpa/legacy/2011/05/05/astrazeneca_cia.pdf

9. Clearly 2010 was not a good year for this Anglo-Swiss company. After a long-running dispute related to the company’s use of transfer pricing techniques to reduce its tax liability in the UK, they agreed to pay £505 Million to settle the matter. http://www.taxresearch.org.uk/Blog/2010/02/23/astrazeneca-to-pay-505m-to-settle-uk-transfer-mispricing-dispute-guardiancouk/

10. 2011 - AstraZeneca settled a related Seroquel case brought by US state governments, agreeing to pay another $69 million for inappropriate marketing of this drug. What is quite comical are the statements made by them when settlements like this crop up: “While we deny the allegations, AstraZeneca believes it is important to bring these matters to a close and move forward”. https://www.firstwordpharma.com/node/843286

11. In August of 2016, AstraZeneca was fined $5,5 Million for making improper payments to foreign officials in China and Russia as incentives to purchase their products.
https://www.sec.gov/litigation/admin/2016/34-78730-s.pdf

These astronomical amounts makes a person marvel at the seemingly negligent impact these fines, awards and settlements have on the overall profits of pharmaceutical companies, most seeing it as the cost of doing business. From 2003 to the present, this company has paid in excess of $1,8 Billion in fines and settlements related to misconduct.

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