Big Pharma Companies Are Convicted Criminals: Check the Records
“We collected data on financial penalties for pharmaceutical firms listed on the Global 500 or Fortune 1000 lists using procedures similar to Almashat et al.1
...Among 26 firms in our sample, 22 (85%) had financial penalties for illegal activities. The combined dollar value of financial penalties totaled $33 billion for 2003 to 2016.
...Four firms were not found to have penalties for illegal activities during the sample period. This may indicate an ability for illegal activity to be undetected, although these firms may instead have effective ethics and compliance programs.”
Arnold DG, Stewart OJ, Beck T. Financial Penalties Imposed on Large Pharmaceutical Firms for Illegal Activities. JAMA. 2020;324(19):1995–1997. doi:10.1001/jama.2020.18740
`The Cost of Doing Business’
Many experts have reported that until the reponsible people at these companies are sentenced to serve prison time for these crimes, instead of just paying fines, it is unlikely that this situation of repeated criminal activity with impunity will get better, in fact, it is more likely to get worse.
Many have also noted that it would have already long ago been appropriate to revoke the business licenses of these companies, and their corporate charters.
The total amount of harm and / or fatalities caused by this illegal activity is unkown, but the number of patients victimized is in the millions.
“Many observers, including myself believe that as long as it is just money that’s involved, it’s not a sufficient deterrent. The drugs that were involved in this settlement earned tens of billions of dollars over a long period of time. So the settlement was less than a single year’s sales of just one of those drugs, Avandia, the drug that I was involved in exposing the risks of. And so it’s just money, and it’s just part of doing business. Many people, particularly on Capitol Hill, believe that it’s time to begin holding these executives accountable for actual jail time when they commit this kind of criminal fraud.”
Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who in 2007 published findings that showed the health risks of the drug Avandia
“GlaxoSmithKline paid nearly $10 billion in inflation-adjusted financial penalties between January 2003 and December 2016, the highest tally for any drug company, according to research published in JAMA. That sum was more than any other in a sampling of 26 companies paying fines inside the U.S.
Pfizer was next in line with almost $3 billion in fines.
Johnson & Johnson came in the third slot with $2.7 billion in penalties.
“The pharmaceutical industry is unique in that all large pharmaceutical firms explicitly state that they are focused on promoting patient welfare, yet the majority of large pharmaceutical firms engage in illegal activities that harm patient welfare,” said Denis G. Arnold, a coauthor of the study and a professor at the University of North Carolina at Charlotte.
“The industry also has the worst reputation of any industry according to Gallup polling. This is an intriguing problem for anyone interested in business ethics and public health,” Arnold stated.
Spokespeople for the three companies could not be immediately reached for comment.
In all, the 26 pharmaceutical companies paid some $33 billion in fines during the 13-year period. The top 11 alone accounted for $28.8 billion, or 88%, of the total.
Financial penalties as a share of revenue were highest (greater than 1%) for Schering-Plough, GlaxoSmithKline, Allergan and Wyeth.”
Largest Fines and Settlements in History
January, 2009:
Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa
$515 Million Criminal Fine Is Largest Individual Corporate Criminal Fine in History; Civil Settlement up to $800 Million
September, 2009:
Pfizer to Pay $2.3 Billion for Fraudulent Marketing
Justice Department Announces Largest Health Care Fraud Settlement in Its History
July, 2012:
GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data
Largest Health Care Fraud Settlement in U.S. History
“The settlement amounts to $1 billion in criminal fees, and a further two billion in civil fees, after the company went to great lengths to promote the drugs, such as providing meals and spa treatments to doctors, that prosecutors stated amounted to illegal kickbacks.”
GlaxoSmithKline pleads guilty to £3bn fraud | IBTimes UK
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations
Monday, November 4, 2013
Johnson & Johnson to pay $5bn in landmark $26bn US opioid settlement
Group of US states attorneys general unveil settlement including three largest US drug distributors and Johnson & Johnson
“In July 2021, the largest pharmaceutical settlement in U.S. history was announced. Totaling $26 billion, the settlement came in response to the allegations that drugmaker Johnson & Johnson and U.S. drug distributors McKesson, Cardinal Health, and AmerisourceBergen “helped fuel a deadly nationwide opioid epidemic,” writes CNBC. The accusations ranged from “lax controls” that allowed for the illegal sale of painkillers to “downplaying the addiction risk” in opioid marketing. All four companies have denied the allegations.”
https://www.grunge.com/754213/the-largest-pharmaceutical-settlements-in-u-s-history/
The Latest Bankruptcy Maneuvers in Talc Powder and OxyContin Litigation
December 18, 2024
Purdue Global Law School
“Johnson & Johnson (J&J) faces over 50,000 lawsuits alleging its talc powder products contain asbestos and have caused cancer in customers. J&J has already lost a number of talc powder litigation cases, resulting in over $4 billion in judgments. In an effort to protect itself from the potentially astronomical costs of the remaining talc powder lawsuits, J&J has tried twice — and failed both times — to file for bankruptcy in New Jersey. Now, J&J hopes to try again, this time in Texas. Meanwhile, in the OxyContin litigation, the Sackler family has recently learned that its attempt to use the bankruptcy process to protect itself has been rejected by the U.S. Supreme Court.”
https://www.purduegloballawschool.edu/blog/news/jj-bankruptcy-talc-powder
“A U.S. bankruptcy court judge has denied Johnson & Johnson’s settlement plan related to baby powder containing talc, providing another setback in the company’s efforts to resolve the matter.
This is the third bankruptcy case for a J&J company as it relates to the baby powder issue.
Red River Talc LLC, a J&J subsidiary, was seeking confirmation of a proposed prepackaged Chapter 11 bankruptcy plan that would have been one of the biggest mass tort settlements in history, if approved. Red River and J&J proposed to pay $9 billion to settle ovarian cancer and other gynecological cancer litigation claims based on talc-related products.
But Judge Christopher Lopez of the U.S. Bankruptcy Court for the Southern District of Texas, Houston division said in a court filing that J&J used a faulty voter solicitation process when dealing with personal injury claimants.”
https://apnews.com/article/johnson-talc-red-river-bankruptcy-tort-92635cde7709ede6712a6a56b1342ee2
Johnson & Johnson Regulatory Violations Summary
Ownership Structure: publicly traded (ticker symbol JNJ)
Headquartered in: New Jersey
Specific Industry: pharmaceuticals
Penalty total since 2000: $25,197,250,170
Number of violation records: 91
safety-related offenses: Number of Records: 27 Penalty Total: $15,185,228,479
https://violationtracker.goodjobsfirst.org/summary?parent=johnson-and-johnson
Merck Regulatory Violations Summary
Ownership Structure: publicly traded (ticker symbol MRK)
Headquartered in: New Jersey
Specific Industry: pharmaceuticals
Penalty total since 2000: $10,710,400,031
Number of violation records: 89
safety-related offenses: Number of Records: 8 Penalty Total: $5,427,585,000
https://violationtracker.goodjobsfirst.org/summary?parent=merck
GlaxoSmithKline (GSK) Regulatory Violations Summary
Headquartered in: United Kingdom
Specific Industry: pharmaceuticals
Penalty total since 2000: $11,772,803,406
Number of violation records: 51
safety-related offenses: Number of Records: 10 Penalty Total: $3,982,642,648
https://violationtracker.goodjobsfirst.org/summary?parent=gsk-plc
Wyeth
“In 1932 American Home Products (AHP) acquired Wyeth Chemical Company (now Wyeth Laboratories), a pharmaceutical manufacturer with a long history, under unusual circumstances. Wyeth was run by family descendants until the death of Stuart Wyeth, a bachelor. He bequeathed the laboratory to Harvard, his alma mater, and the university in turn sold the company to AHP at a generous price.”
“On March 11, 2002, American Home Products Company changed its name to Wyeth, having spun off unrelated businesses in order to focus on pharmaceuticals. Wyeth was a pharmaceutical company until it was purchased by Pfizer in 2009.”
https://rpwrhs.org/w/index.php?title=American_Home_Products_Company
Wyeth: 14 Regulatory Violations Tracker results found
Pfizer Regulatory Violations Summary
Ownership Structure: publicly traded (ticker symbol PFE)
Headquartered in: New York
Specific Industry: pharmaceuticals
Penalty total since 2000: $11,261,560,400
Number of violation records: 107
safety-related offenses: Number of Records: 15 Penalty Total: $5,637,014,255
https://violationtracker.goodjobsfirst.org/summary?parent=pfizer
For details on Pfizer's conviction history, see:
Pfizer’s Criminal Record
I know of two great articles detailing Pfizer’s criminal record. Both are no longer posted on their original web addresses or websites, as far as I can tell. They can be found at the Wayback machine, though. I have posted the link for one here, and also copied the text, for convenience. The link for the second is embeded in the first article, and I have…
Sanofi Regulatory Violations
Ownership Structure: publicly traded
Headquartered in: France
Specific Industry: pharmaceuticals
Penalty total since 2000: $1,698,822,885
Number of violation records: 39
https://violationtracker.goodjobsfirst.org/parent/sanofi
Hawaii court orders drug companies to pay $916 million in Plavix blood thinner lawsuit
“A Hawaii court has ordered the manufacturers and distributors of the blood thinner Plavix to pay the state a combined $916 million after finding the companies failed to disclose the efficacy and safety of the medication, the state attorney general said Tuesday.
The judgement was issued against Bristol Myers Squibb Company and three U.S.-based subsidiaries of French pharmaceutical company Sanofi.”
Sanofi-Aventis to Pay $109 Million Over Illegal Kickbacks
December 22, 2012
https://www.church.law/sanofi-aventis-to-pay-109-million-over-illegal-kickbacks/
Sanofi Agrees to Pay $11.85 Million to Resolve Allegations That it Paid Kickbacks Through a Co-Pay Assistance Foundation
February 28, 2020
Some highlights of manufacturing facility specific concerns and consistent regulatory violations:
“Between 2001 and 2005, GlaxoSmithKline (GSK) manufactured the anti-nausea medication Kytril, the anti-infection ointment Bactroban, the antidepressant Paxil CR, and the diabetes drug Avandamet at a manufacturing facility in Cidra, Puerto Rico. Although GSK closed the manufacturing plant in 2009, in 2010, GSK pled guilty to manufacturing the drugs at the facility without always using the FDA-approved mix of active ingredients. GSK agreed to pay $750 million as part of their criminal and civil settlements.”
https://www.grunge.com/754213/the-largest-pharmaceutical-settlements-in-u-s-history/
GlaxoSmithKline whistleblower awarded $96m payout
Whistleblower who exposed contamination problems at Glaxo plant in Puerto Rico receives $96m
“In August 2002, Eckard, a global quality assurance manager, led a team sent to the plant to investigate manufacturing violations that had been identified by the US Federal Drugs Administration (FDA). Eckard lost her job nine months later after warning that the problems ran deeper than the FDA realised.
Eckard's lawyers, Getnick & Getnick, said she was made redundant against her will in May 2003 after repeatedly complaining to GSK's management that some drugs made at Cidra were being produced in a non-sterile environment, that the factory's water system was contaminated with micro-organisms, and that other medicines were being made in the wrong doses.
Getnick & Getnick said the case was particularly significant because it was so difficult for patients to spot deficiencies with medicines.
"Once the pill is swallowed, it's gone and there may be no way of telling whether someone got sick because the product was bad. As a result of this settlement and guilty plea, drugmakers will now have more reason to live up to their motto that patient safety is their first priority," Skillen said.
The Cidra factory had been GSK's largest manufacturing operation but was closed last year.”
https://www.theguardian.com/business/2010/oct/27/glaxosmithkline-whistleblower-awarded-96m-payout
We Spent a Year Investigating How the FDA Let Risky Drugs Into the U.S. Market
Our investigation exposed a little-known practice inside the FDA that allowed more than 150 drugs or their ingredients into the U.S. over the past dozen years even though they were made at factories banned from shipping their products here.
https://www.propublica.org/article/fda-methodology-american-medicine-research
Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs
Reporting Highlights
“Risky Medications: The FDA has given more than 20 foreign factories a special pass to continue sending drugs to the U.S. even though they were made at plants that the agency had banned.
Troubled Factories: The medications came mostly from plants in India where inspectors found contaminated drugs, filthy labs and falsified records.
FDA Secrecy: The agency did not proactively inform the public when drugs were exempted from import bans, and it did not routinely test the medications to ensure they were safe.”
https://www.propublica.org/article/fda-drug-loophole-sun-pharma
Whistleblower reveals how drug company faked results, Nov 6, 2013
The Truth Pill: The Myth of Drug Regulation in India, By Dinesh Singh Thakur and Prashant Reddy Thikkavarapu
https://www.simonandschuster.com/books/The-Truth-Pill/Dinesh-Singh-Thakur/9789392099229
Doctor tells of fraud and dishonesty at drug giant Ranbaxy
China Rx
Exposing the Risks of America's Dependence on China for Medicine, by Rosemary Gibson and Janardan Prasad Singh
https://www.prometheusbooks.com/9781633883819/china-rx/
...“Citing the concerns of FDA officials and insiders within the pharmaceutical industry, the authors document incidents of illness and death caused by contaminated medications that prompted reform. This probing book examines the implications of our reliance on China on the quality and availability of vital medicines.”
Bottle of Lies
The Inside Story of the Generic Drug Boom, By Katherine Eban
https://www.harpercollins.com/products/bottle-of-lies-katherine-eban?variant=32206330134562
A whistleblower from a manufacturing facility in Kansas:
Dr. Joseph Sansone sits down with Pfizer Whistleblower Melissa McAtee
Some highlights from Merck's criminal history:
"...the notorious and deceptive drug known as Vioxx.
It was a highly marketed arthritis medication that was introduced to the American public in May of 1999, by the German pharmaceutical company Merck.
It ended up being first campaigned for positive health results by the New England Journal of
Medicine, which just so happened to be involved in a conflict of interest.
They were sponsored and funded by the makers of the very drug in question.
Vioxx is one of the biggest drug scandals in American history.
It was estimated to have killed over 60,000 patients according to David Graham, who is the current Associate Director of the Food and Drug Administration’s Office of Drug Safety.
Now compare this figure to the 58,000 American lives lost in the entirety of the Vietnam War.
That means they not only caused more deaths, but were also allowed to gain a source of revenue from the deaths.
The $5 billion dollar fine Merck had to pay may seem significant, until you realize they sold over $11 billion dollars worth of the deadly drug, all while having full knowledge that it caused fatal heart attacks.
That also means that the FDA and the rest of the corrupt government agencies who were involved with Vioxx essentially permitted a foreign company to initiate a sort of biological assault, that targeted the literal heart of the American people.
They killed over 20 times the number of people that were murdered in the 9/11 attacks, yet somehow they were still allowed to generate $6 billion dollars in revenue from it, without facing any prison time.
...We all know that if the average American like you or me were to kill even one person, let alone an entire city worth of people, we would likely be imprisoned for the rest of our life if not sent to death.
And we certainly wouldn’t be allowed to profit from the pain and destruction, which is the system we believe in and voted for.
But somehow they remain above the law, able to commit the same crime 60,000 times over and gain billions from it, all with no real legal consequences.”
Prescription for Disaster: The Vioxx Scandal
https://medium.com/@ericsimpson1125/prescription-for-disaster-the-vioxx-scandal-f1b5796c9631
“The FDA approved Vioxx, Merck's nonsteroidal anti-inflammatory painkiller for the treatment of osteoarthritis, in May 1999. But a few months before the FDA approval came through, Merck launched the Vioxx Gastrointestinal Outcomes Research study (VIGOR) in January 1999. According to the BMJ, the study was meant to prove that Vioxx, also known as rofecoxib, had fewer gastrointestinal side effects than naproxen, another nonsteroidal anti-inflammatory drug.
In the study of over 8,000 people, researchers learned that although Vioxx did decrease the risks of "gastrointestinal events," there was also evidence of an increased risk of a heart attack. However, the published VIGOR study "obscured the cardiovascular risk." Although Dr. Jeffrey Drazen, editor-in-chief of the New England Journal of Medicine, later said that the authors of the VIGOR study had "withheld critical data on the cardiovascular toxicity of Merck's drug Vioxx," none of the authors acknowledged any fault in the study.
Despite the link between cardiovascular incidents and Vioxx, Merck kept the drug on the market for five years. During that time, it's estimated that between 88,000 and 140,000 heart attacks were caused by Vioxx, per New Scientist, resulting in at least 38,000 deaths. Merck finally withdrew Vioxx from the market in September 2004, according to NPR, and by 2007, there were over 27,000 lawsuits against Vioxx for causing heart attacks and strokes. Merck paid a civil settlement of $4.85 billion, though they did "not admit causation or fault.”
https://www.grunge.com/754213/the-largest-pharmaceutical-settlements-in-u-s-history/
Testimony of David J. Graham, MD, MPH, November 18, 2004
“...Good morning. My name is David Graham, and I am pleased to come before you
today to speak about Vioxx, heart attacks and the FDA. By way of introduction, I graduated from the
Johns Hopkins University School of Medicine, and trained in Internal Medicine at Yale and in adult
Neurology at the University of Pennsylvania. After this, I completed a three-year fellowship in
pharmacoepidemiology and a Masters in Public Health at Johns Hopkins, with a concentration in
epidemiology and biostatistics. Over my 20 year career in the field, all of it at FDA, I have served in a
variety of capacities. I am currently the Associate Director for Science and Medicine in FDA’s Office of
Drug Safety.
...In March of 2004, another epidemiologic study reported that both high-dose and low-dose Vioxx
increased the risk of heart attacks compared to Vioxx’s leading competitor, Celebrex. Our study, first
reported in late August of this year found that Vioxx increased the risk of heart attack and sudden death by 3.7 fold for high-dose and 1.5 fold for low-dose, compared to Celebrex. A study report describing this work was put on the FDA website on election day. Among many things, this report estimated that nearly 28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx. I emphasize to the Committee that this is an extremely conservative estimate. FDA always claims that randomized clinical trials provide the best data. If you apply the risk-levels seen in the 2 Merck tria ls, VIGOR and APPROVe, you obtain a more realistic and likely range of estimates for the number of excess cases in the US. This estimate ranges from 88,000 to 139,000 Americans. Of these, 30-40% probably died. For the survivors, their lives were changed forever. It’s important to note that this range does not depend at all on 2 the data from our Kaiser-FDA study. Indeed, Dr. Eric Topol at the Cleveland Clinic recently estimated up to 160,000 cases of heart attacks and strokes due to Vioxx, in an article published in the New England Journal of Medicine. This article lays out clearly the public health significance of what we’re talking about today.”
https://www.finance.senate.gov/imo/media/doc/111804dgtest.pdf
FDA Scientist Says He Faces Retaliation
“Dr. David J. Graham, the Food and Drug Administration scientist who publicly criticized the agency’s approach to drug safety during a Senate hearing last week, said Wednesday that he was facing pressure to transfer to a different job in the FDA -- a move he said was in retaliation for his remarks.”
https://www.latimes.com/archives/la-xpm-2004-nov-25-na-fda25-story.html
“The FDA is inherently biased in favor of the pharmaceutical industry. It views industry as it’s client, whose interests it must represent, It views it’s primary mission as approving as many drugs it can, regardless of whether the drugs are safe or needed.”
2005 David Graham, then associate director of the FDA’s Office of Drug Safety. In an interview given to Fraud Magazine
“He is also speaking out in public against what he describes as a culture of fear within the FDA. “The FDA's suppression and intimidation of scientists is a threat to public health. Unless it changes, and scientists can speak without fear, they cannot defend the public,” he said.
The matter is a pressing one because the US is the world's largest and most lucrative drugs market. Due to a campaign spearheaded in large part by Dr Graham, serious doubts are now being raised on Capitol Hill about whether the FDA as it is currently configured is fit to act as the watchdog of the pharmaceuticals industry.
According to Dr Graham and other critics, the agency is not up to the task because it is too close to the companies it is supposed to be policing. “The FDA has become an agent of industry. I have been to many, many internal meetings and, as soon as a company says it is not going to do something, the FDA backs down. The way it talks about industry is `our colleagues in industry',” he said.
That is not because FDA employees are “people with bad motivations”, Dr Graham said. It is rather because the body is entirely geared towards concentrating on approving drugs, doing little once they are on the market.
“There has been a strong impetus in the FDA to say `yes'. Clinical trials are not designed to address safety and people who handle the approval of a drug also handle post-marketing. But they are not able to make decisions because they have been too closely involved with the approval”, he said.
There is also a problem because, under the Prescription Drug User Fee Act in 1992, the drug industry funds the applications process, and as a consequence puts pressure on the regulator to speed up approvals.
“There is a sense that you get what you pay for. The industry is paying the piper and calling the tune,” Dr Graham said.”
GlaxoSmithKline fraud case: Does crime pay?
As the pharmaceutical giant is fined a record sum of $3bn, we ask if the move will be a deterrent for others.
In the biggest health care fraud settlement in US history, a federal judge approved a fine totalling $3bn for criminal and civil violations by the British pharmaceutical giant, GlaxoSmithKline, last week.
“Glaxo also hired a company to write a medical journal article downplaying the risks.
...And in May, Abbott Laboratories settled for $1.6bn in regard to false marketing of the antiepileptic and mood-stabilising drug Depakote.
So, with the profits over more than a decade of illegal selling far larger than the amount Glaxo agreed to pay, will pharmaceutical companies really be put off? And do drug companies put profits before patients in the US?”
“...it made unsupported claims about the safety of a diabetes drug, anywhere between 50,000 and 100,000 diabetics had unnecessary unneeded heart attacks or death due to the drug Avandia. This drug hurt a lot of people.” GSK wanted doctors to prescribe its products and to convince their colleagues to do the same” That can create a billion-dollar drug and so it bribed some doctors with exotic trips money making speeches and even Madonna concert tickets.
“GlaxoSmithKline was booking billions of dollars a year on the sales of these drugs, and they were doing it for a decade. They knew, from their own compliance program, that they were doing wrong, more than ten years ago, but they made the calculation and did the calculated risk and said, we'll go with it, we'll continue to do the fraud, because at the end, though they'll knick us, we'll pay less money than if we gave up doing the business of fraud. Fraud was profitable so they got more of it.” GSK is one of the world's largest health care companies but it's not the first to be found guilty of violations like this. The firm says mistakes were made and it has learned. Its operating procedures will also be monitored by government officials for the next five years. Alan Fisher, Al Jazeera, Washington.”
Drugmaker GlaxoSmithKline 'guilty of fraud'
“US attorney Carmin Ortiz said: "The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts.
...Despite the large fine, $3bn is far less than the profits made from the drugs. Avandia has made $10.4bn in sales, Paxil took $11.6bn, and Wellbutrin sales were $5.9bn during the years covered by the settlement, according to IMS Health, a data group that consults for drug makers.”
"...The company encouraged sales reps in the US to mis-sell three drugs to doctors and lavished hospitality and kickbacks on those who agreed to write extra prescriptions, including trips to resorts in Bermuda, Jamaica and California.
Psychiatrists and their partners were flown to five-star hotels, on all-expenses-paid trips where speakers, paid up to $2,500 to attend, gave presentations on the drugs. They could enjoy diving, golf, fishing and other extra activities arranged by the company.
GSK also paid for articles on its drugs to appear in medical journals and "independent" doctors were hired by the company to promote the treatments, according to court documents.
GSK held eight lavish three-day events in 2000 and 2001 at hotels in Puerto Rico, Hawaii and Palm Springs, California, to promote the drug to doctors for unapproved use.
Those who attended were given $750, free board and lodging and access to activities including snorkelling, golf, deep-sea fishing, rafting, glass-bottomed boat rides, hot-air balloon rides and, on one trip, a tour of the Bacardi rum distillery, all paid for by GSK.
Air fares were also covered for doctors and spouses, in most cases, and speakers at the event were paid $2,500 each.
Before one event, the compere said: "We have a wonderful and unforgettable night planned. Without giving it all away, I can tell you – you'll be experiencing a taste of luxury."
Not everyone was impressed, though. One psychiatrist complained: "The style of the conference would have been suitable for a convention of cosmetics sales reps; this is supposed to be a scientific meeting. To me, the music, lights, videos, emcees are offputting and a distraction, even demeaning."
GSK also published an article in a medical journal that mis-stated the drug's safety for children, despite the journal asking several times to change the wording.
Copies of the misleading article were given to sales representatives to pass on to doctors in the hope that it would secure more business. Tickets to sports matches were exchanged for discussions about Paxil, with one doctor writing: "Dinner and a Yankee game with family. Talked about Paxil studies in children."
The prosecution said the company paid $275,000 to Dr Drew Pinsky, who hosted a popular radio show, to promote the drug on his programme, in particular for unapproved uses...
A study of 25 people using the drug for eight weeks was pushed by a PR firm hired by GSK, generating headlines...
When a GSK-funded doctor refused to remove safety concerns about the drug from an article he was writing, GSK removed his funding.
The investigation also found that sales representatives set up "Operation Hustle" to promote the drug to doctors, including trips to Jamaica, Bermuda and one talk coinciding with the annual Boston Tall Ships flotilla. Speakers were paid up to $2,500 for a one-hour presentation – up to three times a day – earning far more than they did working in their surgeries.
One speaker, Dr James Pradko, was paid nearly $1.5m by GSK over three years to speak about the drug. He also produced a DVD funded by the company, which was claimed to be independent. It was shown more than 900 times to doctors.
The hope was that doctors would be persuaded to prescribe the drug to patients over its rivals.
The last drug under scrutiny was Advair, GSK's bestselling asthma treatment.
The drug was launched to sales representatives in Las Vegas using images of slot machines, emphasising the bonuses they could make through sales. At the event, the then chief executive, Jean-Pierre Garnier, said: "What is the number one reason why you should love to be a GSK sales rep? Advair's bonus plan. Yeah!"
The company pushed the drug as the ultimate answer for tackling asthma, saying it should be the drug of choice for treating all cases. However, it had been approved only for treating severe cases, as other drugs were more suitable for mild asthma. GSK published material calling mild asthma a "myth" in an attempt to boost sales, according to the prosecution.
About $600,000 a year was given to district sales representatives for entertainment, including regular golf lessons, Nascar racing days, fishing trips, and baseball and basketball tickets.
US attorney Carmin Ortiz said: "The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts."
Despite the large fine, $3bn is far less than the profits made from the drugs. Avandia has made $10.4bn in sales, Paxil took $11.6bn, and Wellbutrin sales were $5.9bn during the years covered by the settlement, according to IMS Health, a data group that consults for drug makers.”
“Consistent with prior research,2 we analyzed all firms that met inclusion criteria and appeared on the list for 7 years or more. All instances of financial penalties from state and federal settlements between January 2003 and December 2016 were obtained from the US Department of Justice, the US Securities and Exchange Commission, the US Environmental Protection Agency, and states’ attorneys general. Each settlement included the penalty amount and described the scope, type, and duration of the associated illegal activity. We secured missing data through Freedom of Information Act requests. Financial penalties were attributed to the settlement year.
...Among 26 firms in our sample, 22 (85%) had financial penalties for illegal activities. The combined dollar value of financial penalties totaled $33 billion for 2003 to 2016. Eleven firms with financial penalties exceeding $1 billion in inflation-adjusted dollars accounted for $28.8 billion (88%) of the total penalties (Table 1). The firms with the highest penalties as a percentage of revenues (ie, >1%) were Schering-Plough, GlaxoSmithKline, Allergan, and Wyeth; the number of penalties for these firms varied between 1 (Allergan) and 27 (GlaxoSmithKline). Four firms had financial penalties that totaled less than $80 million and no more than 2 penalty settlements (Actavis [Watson], Roche Group, Genzyme, and Perrigo). All but 1 firm (Perrigo) engaged in illegal activities associated with penalties for 4 or more years. An additional 4 firms received no financial penalties for illegal activities during this period. The most common types of illegal activity involving penalties (Table 2) were pricing violations, off-label marketing, and kickbacks. The firms with the greatest variety in the types of illegal activities involving penalties were GlaxoSmithKline, Bristol Myers Squibb, and Merck. Three firms (Actavis, Allergan, and Perrigo) had penalties limited to a single violation type.
....Among the large pharmaceutical companies included in this study, 85% had evidence of financial penalties for illegal activities. Given the scope and nature of the illegal activities involving financial penalties, physicians and regulators should exhibit vigilance over the activities of large pharmaceutical firms. Four firms were not found to have penalties for illegal activities during the sample period. This may indicate an ability for illegal activity to be undetected, although these firms may instead have effective ethics and compliance programs.3,4
Limitations of the study include focus on the largest firms, exclusion of class-action settlements and penalties by non-US governments, and the possibility that some settlements were missed. Also, only settlements from a limited time period were examined; whether these data reflect current activities of pharmaceutical companies or whether financial penalties for illegal activities have increased or decreased more recently could not be determined.”
Arnold DG, Stewart OJ, Beck T. Financial Penalties Imposed on Large Pharmaceutical Firms for Illegal Activities. JAMA. 2020;324(19):1995–1997. doi:10.1001/jama.2020.18740
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- Thomas Jefferson
https://founders.archives.gov/documents/Jefferson/01-12-02-0490