Rap Sheet

The purpose of this web page is to demonstrate that the AstraZeneca pharmaceutical company is no different from all the other Big Pharmas in its wrongdoing being widespread and profound and enduring and vicious enough to justify it being considered like all the others to be an offshoot of Organized Crime, as is illustrated below in excerpts first from a Mother Jones account of a single AstraZeneca victim, Dan Markingson, and that followed by two federal prosecutions, and ending in one prosecution each in California, Texas, and Kentucky.

Preliminary versions of Rap Sheets for the leading COVID-19 vaccine manufacturers vying for entry into the US/Canada market have been prepared.  Moderna does not have a rap sheet because it possesses the innocence of the newborn — never having sold any pharmaceutical until just recently its COVID-19 vaccine.  The rap sheet for Astrazeneca is the page you are reading right now.

And the rap sheets for Pfizer and Johnson&Johnson can be accessed by clicking their names.

In none of the three rap sheets has anything close to thoroughness been even attempted, the volume of malpractice and crime being too mountainous.  For immediate purposes, it had been enough to stop not long after having discovered enough information to support the conclusion of an Organized-Crime level of functioning, or in other words to support Dr Peter C Gøtzsche's judgement:  "I asked the question whether we are seeing a lone bad apple now and then, or whether pretty much the whole basket is rotten.  What we are seeing is organised crime in an industry that is completely rotten."

University of Minnesota Blasted for Deadly Clinical Trial
A blistering new government report cites “serious ethical issues” and vindicates a Mother Jones investigation.

Carl Elliott    03Apr2015

Illustration: Sam Weber

It’s not easy to cover up the circumstances around the violent death of a research subject in a botched university drug study.  It’s even harder when the mutilated corpse of the subject is discovered in a blood-soaked bathroom in the middle of the night, the head almost completely severed from the body.  Yet my employer, the University of Minnesota, managed to do just that for nearly eleven years, until two weeks ago, when the state’s Legislative Auditor delivered the results of an eight-month investigation into the case.  The Auditor’s blistering report included evidence of coercion, conflicts of interest, a deeply flawed research oversight system and a series of false and misleading statements by university officials designed to prevent external scrutiny.

Dan and his mom, Mary Weiss

Dan and his mom, Mary Weiss.  Photo: Courtesy Mary Weiss

This story began in 2003, when Dr. Stephen Olson, a psychiatrist at the University of Minnesota used the threat of involuntary commitment to coerce a psychotic young man named Dan Markingson into the so-called “CAFÉ” study: an AstraZeneca-funded trial of antipsychotic drugs aimed at patients experiencing their first psychotic episode.  His mother, Mary Weiss, objected to her son’s enrollment and tried desperately for months to get Dan out of the study, warning Olson and his co-investigator, Charles Schulz, that her son’s condition was deteriorating and that he was in danger of committing suicide.  Her warnings were consistently ignored.  On May 8, 2004, five months into the CAFÉ study, Dan died after trying to decapitate himself with a box-cutter.

The university managed to keep Dan’s violent death out of the public eye until 2008, when the scandal was reported by Paul Tosto and Jeremy Olson in the St. Paul Pioneer Press.  When that report was ignored by university officials, I wrote about the case for Mother Jones.  The study sponsor, AstraZeneca was in the process of settling a half-billion dollar federal fraud investigation, in which unsealed documents suggested that AstraZeneca was rigging, spinning and burying studies in order to market their antipsychotic drug, Seroquel.  Some of those studies appeared to lead to the University of Minnesota.  Specifically, they led to Charles Schulz, the Chair of the Department of Psychiatry and a well-compensated AstraZeneca consultant.

“Thus far, we have buried trials 15, 31, 56 and are considering COSTAR,” an AstraZeneca official wrote in 1999.  “The larger issue is how do we face the outside world when they begin to criticize us for suppressing data.”  As it turned out, the outside world would be brutally critical.  In Mother Jones, I wrote about the role Schulz played in the self-described “smoke and mirrors job” that AstraZeneca performed on Study 15, a notorious trial that cast serious doubt on the efficacy of Seroquel and linked it to weight gain and diabetes.  A year later, Andy Mannix of City Pages did the same with Schulz and the burial of Study 41, which showed an extended-release version of Seroquel to be no better than placebo.

The AstraZeneca study in which Dan Markingson died appeared to be little better.  Psychiatric experts I spoke to called it a “non-study” with “very little value.”  It appeared to be designed not to produce scientifically valid results, but rather to generate a positive marketing message for AstraZeneca.  “It looks like an entirely marketing-driven exercise,” one expert said.  This revelation raised a profoundly disturbing ethical question.  As I wrote in 2010:

But what if a research study is not really aimed at producing genuine scientific knowledge at all?  The documents emerging in litigation suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace.  This raises a question unconsidered in any current code of research ethics.  How much risk to human subjects is justified in a study whose principal aim is to “generate commercially attractive messages”?


US DEPARTMENT OF JUSTICE logo AstraZeneca Pharmaceuticals LP Pleads Guilty to Healthcare Crime; Company Agrees to Pay $355 Million to Settle Charges

[...]  AstraZeneca Pharmaceuticals LP (“AstraZeneca”), a major pharmaceutical manufacturer headquartered in Wilmington, Delaware, today pleaded guilty in federal district court in Wilmington, Delaware to a healthcare crime and agreed to pay $355,000,000 to resolve criminal charges and civil liabilities in connection with its drug pricing and marketing practices with regard to Zoladex, a drug sold by AstraZeneca Pharmaceuticals LP and used primarily for the treatment of prostate cancer.  [...]

(i) Employees of AstraZeneca provided thousands of free samples of Zoladex to physicians knowing and expecting that certain of those physicians would prescribe and administer the free drug samples to their patients and thereafter bill those free samples to the patients and to Medicare, Medicaid, and other federally funded insurance programs;

(ii) In order to induce certain physicians, physicians’ practices, and others to purchase Zoladex, AstraZeneca offered and paid illegal remuneration in various forms including free Zoladex, unrestricted educational grants, business assistance grants and services, travel and entertainment, consulting services, and honoraria; [...]

US DEPARTMENT OF JUSTICE logo Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing

AstraZeneca LP and AstraZeneca Pharmaceuticals LP will pay $520 million to resolve allegations that AstraZeneca illegally marketed the anti-psychotic drug Seroquel for uses not approved as safe and effective by the Food and Drug Administration (FDA) [...].  Such unapproved uses are also known as "off-label" uses because they are not included in the drug’s FDA approved product label.

[...]  [B]etween January 2001 through December 2006, AstraZeneca promoted Seroquel to psychiatrists and other physicians for certain uses that were not approved by the FDA as safe and effective (including aggression, Alzheimer’s disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness).  These unapproved uses were not medically accepted indications for which the United States and the state Medicaid programs provided coverage for Seroquel.

According to the settlement agreement, AstraZeneca targeted its illegal marketing of the anti-psychotic Seroquel towards doctors who do not typically treat schizophrenia or bipolar disorder, such as physicians who treat the elderly, primary care physicians, pediatric and adolescent physicians, and in long-term care facilities and prisons.  [...]

The United States contends that AstraZeneca promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programs.  The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel.  In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct.  AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel.

"Illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers’ pockets," said Attorney General Eric Holder.  "This Administration is committed to recovering taxpayer money lost to health care fraud, whether it’s by bringing cases against common criminals operating out of vacant storefronts or executives at some of the nation’s biggest companies."

The United States also contends that AstraZeneca violated the federal Anti-Kickback Statute by offering and paying illegal remuneration to doctors it recruited to serve as authors of articles written by AstraZeneca and its agents about the unapproved uses of Seroquel.  AstraZeneca also offered and paid illegal remuneration to doctors to travel to resort locations to "advise" AstraZeneca about marketing messages for unapproved uses of Seroquel, and paid doctors to give promotional lectures to other health care professionals about unapproved and unaccepted uses of Seroquel.  The United States contends that these payments were intended to induce the doctors to prescribe Seroquel for unapproved uses in violation of the federal Anti-Kickback Statute.  [...]

Attorney General Kamala D. Harris and 37 Other Attorneys General Announce $68.5 Million Settlement Over Deceptive Marketing of Antipsychotic Drug

SACRAMENTO – California Attorney General Kamala D. Harris and 37 other attorneys general today announced a $68.5 million settlement with AstraZeneca Pharmaceuticals for unfair and deceptive practices in its marketing of the antipsychotic drug Seroquel.

Today’s settlement is the largest multi-state settlement with a pharmaceutical company in history.  California will receive more than $5.2 million, the largest share among the states in the consumer protection settlement.

“The health and well-being of patients should drive drug prescriptions in California, not the profits of a pharmaceutical company,” said Attorney General Harris.  “This settlement puts an end to unscrupulous marketing practices and protects consumers from misguided, and potentially dangerous, treatment with Seroquel for uses the FDA has not approved.”

The complaint, filed today with the proposed judgment, alleges that AstraZeneca promoted Seroquel for unapproved uses, failed to adequately disclose potential side effects to health care providers, and withheld scientific studies that called into question the drug’s safety and efficacy.

Seroquel is an antipsychotic medication used to treat schizophrenia and bipolar disorder.  It was approved by the Food and Drug Administration (FDA) for treatment of these conditions in adults, but AstraZeneca promoted the drug for children and the elderly to treat a variety of medical conditions, including anxiety, depression, post traumatic stress disorder, Alzheimer’s disease and dementia.

Doctors may prescribe medications for unapproved or “off-label” uses, but drug makers are prohibited from promoting drugs for treatment of medical conditions not approved by the FDA.

A three-year investigation, led by the attorneys general of Florida and Illinois, revealed that AstraZeneca also failed to adequately disclose side effects associated with Seroquel, including weight gain, hyperglycemia, diabetes and cardiovascular complications.

As part of today’s settlement, AstraZeneca agreed to not promote Seroquel in a false, misleading or deceptive manner, including for “off-label” uses.  AstraZeneca is required to provide accurate and scientifically balanced responses to requests about off-label usage.  The drug maker is also required to enact policies to ensure financial incentives are not given to salespeople for off-label marketing and post payments made to physicians on a website.

States joining California and the District of Columbia in today’s settlement include Arizona, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.

AG Paxton Recovers $110 Million for Texas in Medicaid Fraud Settlements

Texas Attorney General Ken Paxton today announced that pharmaceutical giant AstraZeneca agreed to pay $110 million to the state of Texas to settle lawsuits alleging that the company falsely and misleadingly marketed two of its drugs in violation of the Texas Medicaid Fraud Prevention Act.

AstraZeneca was accused of engaging in false and misleading marketing schemes at a time when the company was under the strict obligations of a 2010 federal “corporate integrity agreement” resulting from prior allegations of Medicaid fraud.  The federal agreement prohibited AstraZeneca from promoting its antipsychotic medication Seroquel and cholesterol-lowering statin drug Crestor for uses not approved by the FDA, but Texas alleged the company continued to do so anyway.  Such illegal pharmaceutical promotion is commonly referred to as “off-label marketing.”

AstraZeneca allegedly promoted its powerful and potentially dangerous antipsychotic drug to Texas Medicaid providers, who primarily treated children and adolescents when those drugs were not approved as safe and effective for use in that vulnerable population.  Attorney General Paxton’s office accused AstraZeneca of making hundreds of thousands of dollars in illegal payments to two former state hospital doctors to unduly influence the use of Seroquel in the state hospital system.

The company was also accused of a similar nationwide marketing fraud scheme involving Crestor, including allegations that AstraZeneca executed a plan of deception targeted directly at Texas Medicaid to expand the use of the statin beyond what the science supported, while downplaying a significant risk of diabetes in certain patients.

“Texas leads the country in protecting its Medicaid system from pharmaceutical fraud,” Attorney General Paxton said.  “The allegations that led to this settlement are especially disturbing because the well-being of children and the integrity of the state hospital system were jeopardized.  The cooperation and support of the Texas Health and Human Services Commission was essential in achieving this outstanding outcome for Texans.”

The settlements are the culmination of litigation by Attorney General Paxton’s Civil Medicaid Fraud Division. Former AstraZeneca employees provided the initial information to the attorney general’s office under the whistleblower provisions of the Texas Medicaid Fraud Prevention Act.  Since 2000, the attorney general’s office has recovered more than $1.8 billion for taxpayers under the Act.

Attorney General Conway Announces $5.5 Million Settlement With Global Drug Maker AstraZeneca

Attorney General Jack Conway and his Offices of Medicaid Fraud and Abuse Control and Consumer Protection today announced a $5.5 million settlement 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 more than 100 countries.

The settlement resolves allegations that AstraZeneca illegally marketed Seroquel for uses the Food and Drug Administration (FDA) had not approved as being safe and effective.  The FDA has only approved Seroquel for the treatment of schizophrenia and various bipolar disorders in adults.

“I am pleased that we have reached this settlement and are recovering millions of dollars for a vital state program and for taxpayers,” General Conway said.  “We’ve sent a clear message today that Kentucky will not tolerate drug companies that put profits ahead of patient care.”  [...]

AstraZeneca illegally promoted Seroquel’s off-label uses in children and adolescents well before establishing that the drug was not safe or effective for any use by those that age.  AstraZeneca also promoted Seroquel for off-label uses for the elderly, without establishing its safety or effectiveness for elderly individuals.

As a result of AstraZeneca’s unlawful marketing and promotion of Seroquel, utilization of the drug by Kentucky Medicaid recipients dramatically increased. By August, 2004 more than 25 percent of Seroquel users in Kentucky were under 18 years old and approximately 15 percent were older than 65.  As part of its marketing strategy, AstraZeneca sought to induce psychiatrists to switch from prescribing competing drugs for their patients to prescribing Seroquel.  AstraZeneca withheld or failed to disclose negative information concerning the effectiveness of Seroquel, and withheld or failed to adequately disclose the risks associated with using Seroquel.