Who is AstraZeneca? Here are his convictions and controversies

Who is AstraZeneca? Here are his convictions and controversies
(Reading time: 11 - 21 minutes)

This article aims to try to place the pharmaceutical company AstraZeneca in its legal / judicial context and in a broader and even moral way. The need obviously derives from the recent news that AstraZeneca is dealing with the production of the Covid-19 vaccine which, it should be remembered, is still being tested and of which the test results are in many respects doubtful.

We tell you right away that it is not a short article, on the contrary, but it is not our fault if AstraZeneca has also marked its long life in the name of scandals and convictions. We will start by listing the main controversies, convictions and most emblematic bargains of which we have sources for the most part journalistic. Already this could have been enough to place it in the constellation of pharmaceutical companies, but we preferred to deepen and in the second part instead we will list the convictions and plea deals, this time with links to the sentences, which took place in the United States since 2000. This second part will be more precise but less "emotional", in the sense that we can accurately tell you the numbers paid by AstraZeneca because if it is true that there is no database of "Big Pharma convictions", often the American Federal Government and the control bodies that sanction the offenses, they publish the judgments themselves in clear or at least the reasons through official press releases.

It should be remembered that every time you read "off-label use" of pharmaceutical products, for every serious violation, there are dead and damaged behind. These companies live for a single purpose, profit.

One thing is important: none of these companies could have committed these abuses if it had not had the connivance of doctors and scientists. Science and medicine save millions of lives but kill many more for the sole purpose of creating profit. We know that this claim is serious but it is a part of science and medicine that destroyed, perhaps irreparably, the trust relationship between citizens and doctors.


Disputes and convictions

Seroquel case

The pharmaceutical company AstraZeneca has agreed to pay $ 520 million to close federal investigations into marketing practices relating to its drug Seroquel, indicated for schizophrenia. This makes AstraZeneca the fourth largest pharmaceutical company that, in the past three years, has admitted federal accusations of illegal marketing of antipsychotic drugs. The company was accused of misleading doctors and patients by emphasizing research favorable to the drug without properly disclosing other studies related to the fact that Seroquel increases the risk of diabetes.
The New York Times back: "AstraZeneca is still facing over 25000 civil lawsuits from patients who dispute that they have not made the risks of the medicine public."

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Nexium case

On August 16, 2007, Marcia Angell, a former editor of the New England Journal of Medicine and a professor of social medicine at the Harvard Medical School, presents in an interview on Stern, a weekly German-speaking, a complaint that AstraZeneca scientists falsified their research into the efficiency of the drug Esomeprazole: "Instead of using supposedly comparable doses [of each medicine], the company's scientists used Nexium in higher dosages. They compared the 20 and 40 mg Nexium with 20mg Prilosec. With the cards having been marked this way, Nexium looked like an improvement, but it was only a small one and shown in only two of the three studies.
Nexium (esomeprazole) according to the authors is "at the top of the list" of drugs that are marketed by pharmaceutical companies directly to doctors, who receive gifts of money and / or goods when prescribing the drug in question. This behavior by AstraZenenca has resulted in an additional expense of 139,50 million dollars for the German public health system compared to the use of the "old" omeprazole which had the expired patent.[8]

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Corporate sexual harassment

On May 13, 1996, Business Week newspaper reported sexual harassment cases involving 79 women against three Astra executives in the US, including CEO Lars Bildman.

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Case of ex-CEO Lars Bildman

Until June 1996, Lars Bildman CEO in the USA was accused of tax evasion for over $ 1 million, he had stolen corporate funds and hidden his actions from corporate executives, as well as allegations of sexual harassment made to female employees of Astra . The US company Astra has negotiated $ 9,8 million to close the sexual harassment lawsuit.

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Farmatruffa case

In 2007, involved with other pharmaceutical companies in the "farmatruffa" case, the company had to negotiate for 900 thousand euros to be paid to the National Health System. Their informants allegedly persuaded several doctors to make false recipes, some of which were also addressed to dead patients.
At first instance, on October 14, 2010, the judges had imposed 78 sentences between 7 years and 6 months of imprisonment and the payment of compensation for damages to the civil parties, including the Puglia Region, the Order of Doctors and Pharmacists, Asl of Bari , Lecce and Brindisi. According to the accusation, area chiefs and scientific informants of pharmaceutical companies, general practitioners and pharmacists, through false recipes, have pocketed the money for reimbursements for drugs that cost even 400 euros per pack which would then end up in the garbage. The only body to have obtained an immediately executive provisional amount of more than 600 thousand euros had been the Puglia Region which, in the context of the procedure on the legal liability of pharmaceutical companies, had also obtained a compensation equal to 3,2 million euros (acquired from the regional budget). With the second degree sentence declaring the prescriptions revoking all the provisional ones granted by the judges of the first degree, the Regional Advocacy and the Health Policies Area are now verifying the possibility of taking any new compensation actions, not before - Regional sources say - that they consulted the Regional Public Prosecutor of the Court of Auditors '' which, as far as we know, has already started and is initiating autonomous actions of damages, to avoid duplication of claims for damages ''.

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Shadows on the Nobel of Medicine "Piloted Award" 2008

The pharmaceutical company AstraZeneca, which has its headquarters in London, would have probably influenced the awarding of the last prize to medicine - given to Harald zur Hausen for his studies on papilloma virus (Hpv). Two key figures of the selection committee have strong links with the pharmaceutical company. Which, incidentally, has strong interests in the production of the HPV vaccine.
A circumstance that made Christer van der Kwast, director of the Swedish police anti-corruption unit, suspicious. Who ordered a preliminary investigation to ascertain the real development of the facts. Investigators' attention is drawn to Bertil Fredholm, chairman of the commission that evaluates the candidates for the award, and Bo Angelin, member of the 50-person committee that decides the winners. Both have - or have had - ties to AstraZeneca: Fredholm provided advice in 2006, while Angelin sits on the board.
But there is more. The pharmaceutical company - writes the London Times - directly finances both the Nobel foundation website and the subsidiary Nobel Media. How much this sponsorship contract is worth is unknown: neither the foundation nor AstraZeneca wanted to reveal it. But the figure is believed to be in the hundreds of thousands of dollars. A relationship, that between the pharmaceutical company and the Nobel foundation, of an at least improper nature. Which, according to what was revealed by the British newspaper, has caused many anxieties to some members of the foundation itself. At stake, they say, is the respectability of the entire organization.
The Swedish prosecutor in charge of the investigation then raised the dose. And he launched a parallel investigation, again for corruption: it turned out that many commissioners went to China - at the expense of the Chinese government - to explain the selection criteria. "I took the initiative to ascertain whether there are details of an investigation or not," he explained to the Times van der Kwast. So I asked the prosecutor to take care of it. " However, a spokesman for the pharmaceutical company denied any embezzlement. "We - explained the spokesman - have no influence on the commission that decides the winners of the Nobel prize nor do we aspire to have them". «Bo Angelin's involvement with the foundation - he continued - is completely independent of his role in the company. Bertil Fredholm, on the other hand, is a known expert. He did some work for us in 2006 as on the other hand we happen to have to deal with other people who have experience in their field. Our relationship has not gone further ».

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Tax dispute in the UK

The pharmaceutical company has agreed to pay 505 million pounds in a case involving the complex intercompany tax accounting system known as transfer pricing, which allows companies to record profits from a subsidiary in a high-tax area to one in a low-tax jurisdiction, minimizing tax payments. However, authorities are increasingly lowering transfer prices as part of an international tax avoidance offensive that has the backing of the President of the United States, Barack Obama.
AstraZeneca has stated that it makes over 70% of its profits abroad and pays the necessary taxes abroad. However, the American division of AstraZeneca was named in 2004 as one of the 30 companies involved in a tax avoidance plan sold by the US company KPMG. The scheme is estimated to have cost the US tax authorities, who called it "abusive", with lost revenue of nearly £ 1 billion.

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Marvecs Italy case

The prosecutors of Milan Gaetano Ruta and Luigi Orsi have requested the indictment for 23 people, including managers and advisers or former directors of the Italian divisions of the multinationals of the pharmaceutical sector Pfizer and Astrazeneca, all accused of fraudulent bankruptcy.
The investigation, conducted by the Tax Police Unit of the Gdf of Milan, had been closed in recent months and would have ascertained that a company operating in the marketing of pharmaceutical products, Marvecspharma Service srl (which went bankrupt in January 2011), after increasing its workforce due to some sales of business branches by the multinationals of the drug, Pfizer and Astrazeneca, and received by way of negative goodwill sums of more than one hundred million euros, has failed to pay into the closed-end fund of the category employees 'Pharmaceutical Scientific Informers' the related severance pay and withholdings made as substitute tax, for amounts greater than 12 million euro. The company, according to the prosecution, would also have purchased equity investments in associated companies for several tens of millions of euros and paid consultations of dubious nature and effectiveness, closing the various financial years always at a loss, until bankruptcy.
The trial request concerns Nicola Danzo and Francesco Danzo, arrested in July 2011 and to whom Marvecspharma Service srl and Ellenerre srl were connected, and a series of managers or former managers of Pfizer Italia (Per Oluf Olsen, Francesco De Pari, Marco Pacini, Martin Thomas, Maria Pia Ruffilli, Soren Celinder and Silvio Mandelli) and of Astrazeneca spa (Hans Sijbesma, Fausto Massimino and Luigi Felice La Corte).
According to the accusation, the managers of the two multinationals and of two other companies, Pharmacia Italia and Simesa, in competition with the managers of Marvecspharma Service srl, would have dissipated "the corporate assets" and caused "the failure" of this 'last company, through' 'malicious'' operations, in particular with the sale of company branches. A series of acquisitions that, according to the prosecutors, would have burdened the company "with bankruptcy charges due to workers and social security institutions for amounts that exceeded its capital capacity". The preliminary hearing is expected to be set for March. (HANDLE).

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Italy antitrust case

The president of the Italian antitrust commission in June 2013 in the usual annual report presented to parliament, it stigmatizes the dominant behavior of some pharmaceutical multinationals including AstraZeneca, underlining its behavior. The report confirmed the first instance judgment of the General Court in the AstraZeneca case and, consequently, the correctness of the initial Commission decision (the decisions of the Court of Justice, the General Court and the Commission are available respectively here , here e here ). "The Commission drew attention to the prejudices to competition that can arise in this market through regulatory gaming, first with a fact-finding investigation and then with the decision on the AstraZeneca case, in which the abuse of a dominant position by a company that exploited the folds of regulation to illegally maintain an exclusive position. The decision was confirmed by the Court of Justice in December 2012. "
In addition to the amount of the sanction (a good 53 million Euros), the AstraZeneca case is of extreme interest for having definitively confirmed some obligations that affect all companies in a dominant position that interface with the patent offices. As is known, AstraZeneca's behavior deemed abusive had consisted in having communicated to some national patent offices, as a date corresponding to that of the first marketing authorization on European territory, a date subsequent to that of the first marketing authorization trade obtained in France for the drug in question (ie Losec, the branded drug of AstraZeneca based on omeprazole). This communication had not been corrected even afterwards, despite the fact that AstraZeneca had received requests for clarifications from some patent offices. On this basis, AstraZeneca had therefore obtained complementary protection certificates for omeprazole which - as the Commission considers - the competent patent offices would not have issued had they known of the existence of the previous French marketing authorization

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Top 5 AstraZeneca's favorite crimes in the United States of America

Compared to other pharmaceutical companies that often use satellite companies, in fact they are controlled, out of 21 cases related to AstraZeneca, only one case results from its subsidiary. Recall that the figures that you will see should be compared to a turnover of 24,38 billion dollars in 2019 alone while the sentences are from 2000 to 2018. One could safely say that they did not affect in any way the company liquidity or, said more down to earth , violate the pay law.

  Top 5 of AstraZeneca's favorite offenses
Total paidconvictions
  Health related offenses$ 594.000.000 
4
  Offenses related to government contracts$ 543.241.159 
12
  Offenses related to competition$ 5.522.000  1
  Offenses related to consumer protection$ 5.391.000  1
  Employment related offenses
$ 600.000 2

Top 15 of the sentences sentenced to AstraZeneca in the United States of America

NOTE: The False Claims Act does not exist as structured by us, it is also called "Lincoln Law" and is an American federal law that imposes responsibility on people and companies that defraud government programs. It is the primary tool for federal government litigation in combating government fraud.

# 1 - $ 520.000.000

April 27 2010 - Poff-label or unapproved promotion of medical products

AstraZeneca LP e AstraZeneca Pharmaceuticals LP pagheranno 520 milioni di dollari per risolvere le accuse secondo cui AstraZeneca ha commercializzato illegalmente il farmaco antipsicotico Seroquel per usi non approvati come sicuri ed efficaci dalla Food and Drug Administration (FDA), i Dipartimenti di giustizia e salute e servizi umani 'Ha annunciato oggi il Team di azione antifrode per l'assistenza sanitaria (HEAT). Tali usi non approvati sono anche noti come usi "off-label" perché non sono inclusi nell'etichetta del prodotto approvato dalla FDA del farmaco. Gli Stati Uniti affermano che AstraZeneca ha commercializzato illegalmente Seroquel per usi mai approvati dalla FDA. In particolare, tra gennaio 2001 e dicembre 2006, AstraZeneca ha promosso Seroquel a psichiatri e altri medici per determinati usi che non sono stati approvati dalla FDA come sicuri ed efficaci (tra cui aggressività, morbo di Alzheimer, gestione della rabbia, ansia, disturbo da deficit di attenzione e iperattività, mantenimento bipolare , demenza, depressione, disturbo dell'umore, disturbo post traumatico da stress e insonnia). Questi usi non approvati non erano indicazioni accettate dal punto di vista medico per le quali gli Stati Uniti e i programmi statali Medicaid fornivano copertura per Seroquel. AstraZeneca ha promosso gli usi non approvati influenzando indebitamente gli informatori scientifici nei programmi di educazione medica sponsorizzati dall'azienda. La società ha anche incaricato i medici di offrire programmi promozionali su usi non approvati per Seroquel e di condurre studi sugli usi non approvati di Seroquel. Inoltre, la società ha reclutato medici per servire come autori di articoli scritti da società di letteratura medica e su studi che i medici in questione non hanno condotto. AstraZeneca ha quindi utilizzato quegli studi e articoli come base per messaggi promozionali sugli usi non approvati di Seroquel.

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#2 - $ 354.900.000

20 June 2003 - False Claims Act

AstraZeneca Pharmaceuticals LP has pleaded guilty to the Wilmington Federal District Court, Delaware, and has agreed to pay $ 354,9 million to resolve criminal charges and civil liability in connection with its drug prices and marketing practices related to Zoladex, a drug used primarily for the treatment of prostate cancer. AstraZeneca agreed to pay a $ 63,9 million fine as part of the alleged guilty of conspiring to violate the Prescription Drug Marketing Act by causing requests to pay for the Zoladex prescription that had been provided as a free sample to urologists. AstraZeneca has agreed to discharge its federal civil liability under the False Claim Act and to pay $ 266,1 million to the United States government to resolve the allegations that have resulted in false and fraudulent claims being filed with Medicare; another $ 24,9 million had to be paid to states to resolve similar claims regarding Medicaid.

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#3 - $ 110.000.000

August 7th, 2018 - Rand related to government contracts

AstraZeneca agreed to pay $ 110 million to the state of Texas to resolve the disputes claiming that the company falsely and misleadingly marketed two of its drugs in violation of the Texas Medicaid Fraud Prevention Act.

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# 4 - $ 46.500.000

July 6 2015 - False Claims Act

AstraZeneca LP has agreed to pay the United States and participating States a total of $ 46,5 million, in addition to interest, to resolve allegations that knowingly underpaid rebates owed under Medicaid's Drug Discounts Program .

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# 5 - $ 14.700.000

October 15, 2009 - False Claims Act

AstraZeneca was found guilty by a Kentucky Medicaid fraud jury by declaring inflated average wholesale prices of his medications and was ordered to pay $ 14,7 million.

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# 6 - $ 7.900.000

February 11 2015 - Offenses related to government contracts

Delaware-based pharmaceutical manufacturer AstraZeneca LP has agreed to pay the government $ 7,9 million to liquidate the allegations that it initiated a kickback system in violation of the False Claims Act. Pharmaceutical companies that pay bribes to increase profits will be held accountable for their improper conduct, "said US Special Inspector General (HHS-OIG) Department of Health and Human Services Special Agent Nick DiGiulio." We will continue to repress these actions that can undermine pharmacological choices for patients and corrode public trust in the health system ".

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# 7 - $ 5.522.000

August 30th, 2016 - Offenses related to competition

For at least 2010, AZN has failed to devise and maintain a sufficient system of internal accounting controls related to the interactions of its branches in China and Russia with government officials, most of whom were healthcare providers ("HCPs"), at the state-entity owned and controlled by the state in China and Russia. Sales and marketing staff, along with different management levels at the two AZN branches, designed and authorized several schemes to make improper gift payments, conference support, travel, cash and other benefits to healthcare professionals to reward or influence their purchases of AZN pharmaceutical products. In addition, employees of the Chinese affiliate made cash payments to local officials to reduce or avoid fines imposed on the Chinese affiliate. AZN incorrectly recorded all improper payments from its subsidiaries in China and Russia as bona fide commercial expenses in its consolidated financial statements.

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# 8 - $ 5.500.000

February 7 2013 - Poff-label or unapproved promotion of medical products

Attorney General Jack Conway and his Medicaid Fraud and Abuse Control Offices and Consumer Protection today announced a $ 5,5 million deal with AstraZeneca Pharmaceuticals LP to resolve allegations of off-label marketing of the atypical antipsychotic drug Seroquel. AstraZeneca, headquartered in London, England, is a global pharmaceutical manufacturer operating in over 100 countries. AstraZeneca illegally promoted the off-label uses of Seroquel in children and adolescents well before establishing that the drug was not safe or effective for any use by those who age. AstraZeneca also promoted Seroquel for off-label uses for the elderly, without establishing its safety or efficacy for the elderly.

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# 9 - $ 5.391.000

January 27 2010 - Breach of consumer protection

Following a previous guilty verdict at the trial, AstraZeneca was sentenced to pay $ 5,3 million in civil fines for violations of the Kentucky Consumer Protection Act for wrongly declaring the average wholesale price of its drugs.

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# 10 - $ 3.333.333

October 6, 2010False Claims Act

AstraZeneca, GlaxoSmithKline and Novartis have agreed to pay $ 10 million as part of a series of settlements between pharmaceutical companies and Hawaii on charges of publishing inflated drug prices and therefore increasing Medicaid costs. The announcement did not specify how this amount would be split between the three companies. Here we assume that it has been divided equally between them.

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# 11 - $ 2.600.000

October 6, 2010False Claims Act

AstraZeneca agreed to pay $ 2,6 million for multi-state dispute resolution claiming that it violated the False Claims Act by failing to pay adequate discounts for drugs paid for by Medicaid. Also involved in the settlement was the United States Department of Justice, which made its announcement

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# 12 - $ 2.500.000

August 11th, 2011 - False Claims Act

AstraZeneca Pharmaceuticals LP and AstraZeneca LP have agreed to pay $ 2,5 million in resolving allegations that incorrectly reported the average wholesale price of their drugs.

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# 13 - $ 807.826

August 11th, 2011 - False Claims Act

AstraZeneca has agreed to pay $ 807.826 to settle the allegations that has overburdened Medicaid for the drug Zoladex by not including promotions, free goods, discounts, rebates and other price reductions in the price paid by the Florida Medicaid Program. Attorney General Charlie Crist he stated that "We will not let our citizens get cleaned up by companies that cheat taxpayer-funded programs ... This case is about the greed and advantage of those who have no choice in the drugs they buy."

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# 14 - $ 350.000

March 28 - Discrimination at work

Case # 06-022564-CL. Being the cause between a private citizen and AstraZeneca, we only know of a generic "discrimination at work based on age. "


# 15 - $ 250.000

June 6 2011 - Discrimination at work

AstraZeneca agreed to pay $ 250.000 to 124 women who were discriminated against while working at the company's Philadelphia Business Center. The action resolved a lawsuit filed by the United States Department of Labor in May 2010 claiming that the company discriminated against women sales specialists by paying wages that were, on average, $ 1.700 less than their male colleagues.

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