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Not very long ago, issues like patents, trademarks, copyright, etc, collectively called intellectual property rights (IPRs), were sort of alien subjects relating mainly to foreign companies and some large Indian companies. However, people have become more conscious of their rights regarding their creations. The past...
The government has fined drug companies billions of dollars for illegally promoting drugs for unapproved uses. Here's a closer look at six of the most recent major fraud fines
On Monday, the Department of Justice announced that drug company GlaxoSmithKline agreed to pay a $3 billion fine, the largest health care fraud fine in the history of the United States. This fine is just the latest in a string of drug company penalties for improper promotion of drugs for "off-label," or unapproved, uses. Here we take a look at six recent multi-million dollar fines that drug companies have agreed to pay for inappropriately, and in some cases illegally, promoting prescription drugs.
Eli Lilly was fined $1.42 billion to resolve a government investigation into the off-label promotion of the anti-psychotic Zyprexa. Zyprexa had been approved for the treatment of certain psychotic disorders, but Lilly admitted to promoting the drug in elderly populations to treat dementia. The government also alleged that Lilly targeted primary care physicians to promote Zyprexa for unapproved uses and "trained its sales force to disregard the law."
Pfizer was fined $2.3 billion, then the largest health care fraud settlement and the largest criminal fine ever imposed in the United States. Pfizer pled guilty to misbranding the painkiller Bextra with "the intent to defraud or mislead", promoting the drug to treat acute pain at dosages the FDA had previously deemed dangerously high. Bextra was pulled from the market in 2005 due to safety concerns. The government alleged that Pfizer also promoted three other drugs illegally: the anti-psychotic Geodon, an antibiotic Zyvox, and the anti-epileptic drug Lyrica.
AstraZeneca was fined $520 million to resolve allegations that it illegally promoted the anti-psychotic drug Seroquel. The drug was approved for treating schizophrenia and later for bipolar mania, but the government alleged that AstraZeneca promoted Seroquel for a variety of unapproved uses, such as aggression, sleeplessness, anxiety, and depression. AstraZeneca denied the charges but agreed to pay the fine to end the investigation.
Merck agreed to pay a fine of $950 million related to the illegal promotion of the painkiller Vioxx, which was withdrawn from the market in 2004 after studies found the drug increased the risk of heart attacks. The company pled guilty to having promoted Vioxx as a treatment for rheumatoid arthritis before it had been approved for that use. The settlement also resolved allegations that Merck made false or misleading statements about the drug's heart safety to increase sales.
Abbott was fined $1.5 billion in connection to the illegal promotion of the anti-psychotic drug Depakote. Abbott admitted to having trained a special sales force to target nursing homes, marketing the drug for the control of aggression and agitation in elderly dementia patients. Depakote had never been approved for that purpose, and Abbott lacked evidence that the drug was safe or effective for those uses. The company also admitted to marketing Depakote to treat schizophrenia, even though no study had found it effective for that purpose.
GlaxoSmith Kline agreed to pay a fine of $3 billion to resolve civil and criminal liabilities regarding its promotion of drugs, as well as its failure to report safety data. This is the largest health care fraud settlement in the United States to date. The company pled guilty to misbranding the drug Paxil for treating depression in patients under 18, even though the drug had never been approved for that age group. GlaxoSmithKline also pled guilty to failing to disclose safety information about the diabetes drug Avandia to the FDA.
Source: The Department of Justice.
GlaxoSmithKline has pleaded guilty to criminal charges, and agreed to pay $3 billion in fines for various sins. Well, GSK is not alone. GSK has been caught doing what all pharma companies do most of the time, as I have been warning for decades
“Power corrupts. Knowledge is power. Study hard. Be evil.”— Anon
This seems to be the hot news in the US today. But for me this is no news at all. This happens with all companies and all drugs all the time. I have been warning people about this for decades. I feel happy today that many of my detractors will feel bad that a governmental agency has been able to spot this fraud! Read the news as it is below:
Washington—Global healthcare giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today. The resolution is the largest health care fraud settlement in US history and the largest payment ever by a drug company.
GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce; and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). Under the terms of the plea agreement, GSK will pay a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600. The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s US president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the US district court.
What makes this interesting are the revelations further of what GSK has been doing which again is what all companies do but, let us see it from the source.
“GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended.”
“The United States contends that GSK paid millions of dollars to doctors to speak at and attend meetings, sometimes at lavish resorts, at which the off-label uses of Wellbutrin were routinely promoted and also used sales representatives, sham advisory boards, and supposedly independent Continuing Medical Education (CME) programs to promote Wllbutrin for these unapproved uses.”
In the past I had written about a good book “The truth about drug companies—How they deceive the public and what to do about it” by the former editor of the prestigious New England Journal of Medicine, Marcia Angell. She was the editor for 20 years and before that her husband, Relman, was there for 20 years. Both of them are now fighting the drug company menace in the USA. This book will let the reader have all the inside dealings of the drug lobby to sell their wares even when they know that the drugs that they were going to launch could kill many people. They do not want their share holders to lose their money. Here is one case in the open now. GSK was fully aware that the glitazone that they were going to release to the market could result in heart attacks in the recipient but they wanted to make enough money before that comes out in the open. Obviously, for them patient deaths were just statistics but their profit was sacrosanct!
The said company was well aware of the dangers of administering anti-depressants to children below the age of 18. They not only used dubious methods to promote the drug for depression in those below 18 years of age but they invented new indications like attention disorder, etc in children to sell the drugs. Antidepressants in children could increase their suicidal tendency! In her beautiful book “Dementia—a crime against mankind” by Elizabeth Grace Jackson, a professor of psychiatry in the US Navy, she gives us the dangers of antidepressants in general and shows how the epidemic of dementia these days is due to abuse and overuse of psychiatric drugs!
The other big criminal act by the drug companies is to sponsor the so called Continued Medical Education (CME) for doctors. It should instead be called “Continuing Brain washing of Doctors” by drug companies (CBD). The scenario is the same in India. Of course, we ape the Americans in every sphere of human activity, more so in medicine. You have now realized what the receptionist means when she tells you to come after the doctor has returned from the conference. John Ioannidis MD, DSc from Stanford University is an expert in finding the loopholes in our medical system. His recent paper “Are medical Conferences useful?” in the prestigious JAMA (JAMA. 2012;307:1257-1258) gives the following facts about conferences, which I call as CBDs.
“Do medical conferences serve any purpose? In theory, these meetings aim to disseminate and advance research, train, educate, and set evidence-based policy. Although these are worthy goals, there is virtually no evidence supporting the utility of most conferences. Conversely, some accumulating evidence suggests that medical congresses may serve a specific system of questionable values that may be harmful to medicine and health care. Power and influence appear plentiful in many of these meetings. Not surprisingly, the drug, device, biotechnology, and health care–related industries make full use of such opportunities to engage thousands of practicing physicians. Lush exhibitions and infiltration of the scientific program through satellite meetings or even core sessions are common avenues of engagement. Although many meetings require all speakers to disclose all potential conflicts, the majority of speakers often have numerous conflicts, as is also demonstrated in empirical evaluations of similar groups of experts named on authorship lists of influential professional society guidelines.”
“Meetings may also create a branding system that builds the reputations of scientists working in the field and promotes herding after elevated prestigious opinion leaders. Opinion leaders are experts whose valued utterances can exercise wide influence regardless of, in the absence of, or even against evidence. Gaining the podium for the plenary presentation or important sessions at a major meeting confers prestige, even though there is little safeguard that what these featured speakers say has any value and quality. Each professional society and organization creates its cadre of leaders, with meetings making these leaders visible to the members who usually participate passively by listening. Given the dynamics of large professional societies and conferences, leadership is sometimes judged not on scientific merit, hard work, and originality of thought but rather on the ability to navigate power circles. Some young scientists may be even discouraged to think that merit, hard work, and originality of thought is what counts. Instead, they may struggle to become better positioned within influential societies, with the hope that they will some day gain a spot on the podium of the specialty arena.”
One of my friends, an industrialist, had recently gone to Singapore for a cruise. To his wife’s surprise 98% of the passengers were Indian. She was very proud of our country to know how rich our people were. Next morning during breakfast she had a group of ladies talking to her. She found out that all of them in the ship were from one city in India and they were all doctors and their spouses! The cruise was booked by one drug company in return for the favours done! My friend’s wife had a shock of her life. She has not been seeing doctors for minor complaints ever since!
Instrument companies do not lag behind either. For each cardiac stent inserted for example the company budgets a small amount of $500 as doctors’ hospitality. The manufacturing cost is just about $10. The company might make a small profit of just $1490 or so per stent! This assessment of mine might be subject to revision recently! All that glitters is not gold in the field of human healing. Are you now happy that medical arena is one big business where profit is the ONLY motto irrespective of consequences based on the corporate principle of Bernard Mandeville, Adam Smith’s teacher. Long live mankind on tender loving care of good humane doctors who have not fallen prey to this yet. They have lots of temptations. I am happy to let you know that there are many such good souls who are not hard to find if you look carefully even today.
“Yes! Finally captured Martha Stewart. You know, with all the massive and almost completely unpunished fraud perpetrated on the American public by such companies as Enron, Global Crossing, Tyco and Adelphia, we finally got the ringleader. Maybe now we can lower the nation's terror alert to periwinkle.”— Jon Stewart.
(Professor Dr BM Hegde, a Padma Bhushan awardee in 2010, is an MD, PhD, FRCP (London, Edinburgh, Glasgow & Dublin), FACC and FAMS. He is also editor-in-chief of the Journal of the Science of Healing Outcomes, chairman of the State Health Society’s Expert Committee, Govt of Bihar, Patna. He is former vice-chancellor of Manipal University at Mangalore and former professor for cardiology of the Middlesex Hospital Medical School, University of London. Prof Dr Hegde can be contacted at [email protected])