Big Pharma in Big Troubles and Scandals !

Unfair practices: Pharma cos GlaxoSmithkline, Pfizer, Johnson & Johnson and others fined $13 bn in 4 years 16 JUL, 2012, 11.03AM IST, SUBODH VARMA,TNN  NEW DELHI: In the past four years, leading members of Big Pharma like GlaxoSmithkline, Pfizer, Johnson & Johnson, AstraZeneca, Merck, Abbot, Eli Lilly and Allergen have paid about $13 billion in fines to settle charges of misleading marketing, promising what drugs don't do, bribing doctors to get their drugs prescribed, causing sometimes fatal side-effects, and other crimes. The patients targeted by them ranged from children to dementia afflicted senior citizens. An analysis of their total revenues and the income from the drugs they are charged with shows that while huge, the fines are at best slaps on the wrist - their jaw-dropping revenues far outweigh the penalties. Here are the facts: GlaxoSmithKline was fined $3 billion by the US justice department for marketing drugs for unapproved uses, paying kickbacks to doctors and Medicare system, downplaying known risks of certain drugs. They sold Paxil, an antidepressant, to children for whom it was not shown to work. They sold Wellbutrin, another anti-depressant, as a pill for weight-loss and erectile dysfunction. They sold the anti-diabetic pill Avandia concealing data that showed it increased cardiac risks. But in the years it took for all this to come through GlaxoSmithkline had made $11.6 billion on Paxil, $5.9 billion on Wellbutrin and $10.4 billion on Avandia. That's $27.3 billion - about 9 times the fine they are paying now to settle investigations. Pfizer, the world's biggest pharma company with annual revenue of over $67 billion last year, paid up $2.3 billion in 2009 to settle a similar investigation. The drugs involved were Bextra, Geodon, Zyvox and Lyrica. Pfizer had been using illegal methods to sell them, like giving junkets and cash to sales reps for pushing the anti-arthritic pain killer Bextra as an all-purpose pain killer. The reason for Pfizer's huge fine was that it included $1.3 billion for criminal liability - because this was the second time they had been caught. Earlier, in 2004, their subsidiary Warner-Lambert had been fined $430 million for the same violations, and they had promised never to repeat. All four of Pfizer's controversial drugs had topped $1 billion in sales before coming under a cloud. And so it goes on. Johnson & Johnson has appealed against an Arkansas judge's ruling to cough up $1.2 billion for off-label marketing of Risperdal, Medicaid fraud and paying kickbacks to nursing care provider Omnicare. But industry experts say that J&J is going to settle with justice department for $2.2 billion and avoid nationwide penalties which would run into billions. Risperdal is estimated by industry analysts to have earned $24 billion for J&J since it went on sale in 2003 as an antipsychotic drug. Abbott Laboratories aggressively pushed the anti-epilepsy blockbuster drug Depakote on elderly dementia patients saying that it helped control their agitation. There was no evidence that it did so. In fact, there was evidence of adverse effects. They also sold it as an anti-schizophrenia drug whereas it was approved only for seizures and bipolar mania. This year, Abbott agreed to settle all claims for $1.6 billion. Abbott had $38.85 billion sales last year. In 2011, Merck agreed to pay a fine of $950 million for selling Vioxx, a painkiller for four years before withdrawing it in 2004. It earned about $11 billion from Vioxx, but left behind a trail of patients with heart seizures and strokes.  

Blowing the Whistle on Illegal Behavior in Big Pharma By discovering the next "miracle" pharmaceutical, drug companies not only improve many people's lives, but also stand to earn substantial profits. OAKLAND, CA, July 09, 2012 /24-7PressRelease/ -- By discovering the next "miracle" pharmaceutical, drug companies not only improve many people's lives, but also stand to earn substantial profits. While it is important that companies be compensated for the time and effort spent developing and testing new drugs, the desire to earn profit can also lead drug companies to cut corners while investigating the safety of new drugs, cherry-pick data, mislead about test results and ultimately put many people at risk of being catastrophically injured by new drugs. The law does, however, provide protection for employees and scientists in the pharmaceutical industry who blow the whistle on unethical and illegal behavior. It is illegal to retaliate against these whistleblowers.

PanHER Case While the drug PanHER was being tested by Pfizer as a cancer treatment, an executive discovered problems with the research, reports Courthouse News Service. Specifically, the executive found hundreds of instances of prohibited drugs being used by people in the study and also noticed that adverse events caused by PanHER were not reported to the Food and Drug Administration. Because of the use of prohibited drugs by the test patients, the result of the study of PanHER was misleading, and potentially grossly inaccurate. The executive brought these findings to her superiors at Pfizer, who reportedly did nothing to rectify the errors. The executive claims that after the findings were reported, the company created a hostile work environment. The executive did transfer out of the PanHER program, but was ultimately fired from the drug company. After being fired, the executive filed a lawsuit, Ferretti v. Pfizer, claiming that Pfizer retaliated against her for doing the right thing and blowing the whistle on the test results.

California Law California law prohibits an employer from retaliating against an employee who "discloses a violation or noncompliance with a state or federal statute, rule, or regulation." Further, an employer is prohibited from retaliating against an employee who refuses to participate in "an activity that would result in a violation of state or federal statute, or a violation or noncompliance with a state or federal rule or regulation." Strict federal rules and regulations govern the testing process for new drugs, to ensure that only safe medications are marketed. Retaliation can take many forms, including: - Discharge - Failure to promote In the pharmaceutical industry, whistleblower protections could potentially save millions of people from the harmful side effects of an unsafe drug. However, these whistleblower protections are not limited to just employees looking to protect the health and safety of others, but also can protect whistleblowers who disclose other illegal or fraudulent activities. Sadly, the PanHER case is not the exception in the pharmaceutical industry, and corner cutting is a major concern to consumers. Recently, large pharmaceutical company GlaxoSmithKline was fined $3 billion for promoting and selling antidepressants for uses not approved by the Food and Drug Administration and not fully disclosing safety data concerning one of its diabetes drugs, according to the New York Times. If you have information that your employer is engaging in illegal or fraudulent activity or is otherwise lying or providing false information to a government agency, speak with an attorney to know if can blow the whistle without fear of retaliation. At Gwilliam, Ivary, Chiosso, Cavalli & Brewer, our mission for the last 30 years has been clear: Obtain the best possible result for each of our clients and, in so doing, help create a safer and more just community for everyone. As a firm, we are committed to giving each case and every client our very best. For this reason, we only accept those cases we truly believe in. By putting maximum effort into each case, we have been able to obtain multi-million dollar verdicts or settlements for many of our clients. We take the time to get to know our clients as human beings and not just a legal case. We do our best to provide our clients with the services they need - even those extending beyond the legal arena. Gwilliam, Ivary, Chiosso, Cavalli & Brewer, P.C.   

GlaxoSmithKline's bribes are evidence that Big Pharma isn't working The inadequacies of relying solely on market forces for our drugs are clearer than ever. This scandal should prompt a rethink Philip Ball guardian.co.uk, Wednesday 4 July 2012 14.45 BST GSK's anti-depressant drug for adults, Paxil, which the company was promoting to under 18s. Photograph: Joe Raedle/Getty Images Perhaps the most shocking thing about the latest GlaxoSmithKline drug scandal is that malpractice among our overlords still has the ability to shock at all. Yet despite popular cynicism about doctors being in the pockets of the drug companies, there remains a sense that the people responsible for our healthcare are more principled and less corruptible than expenses-fiddling politicians, predatory bankers, amoral media magnates and venal police. If this were a junk food company lying about its noxious products, or a tobacco company pushing ciggies on schoolkids, we'd be outraged but hardly surprised. When a major pharmaceutical company is found to have been up to comparable misdemeanours – bad enough to warrant an astonishing $3bn fine – it seems more of a betrayal of trust. This is absurd, of course, but it shows how the healthcare industry benefits from its proximity to the Hippocratic oath. "Do more, feel better, live longer" GSK purrs. How can we doubt a company that announces as its priorities as "improving the health and wellbeing of people around the world" and "being open and honest in everything we do"? Now GSK admits that, in effect, it risked damaging the health of people around the world, and was secretive and fraudulent in some of what it did. Among other things, it promoted antidepressant drug Paxil, approved only for adults, to people under 18. It marketed other drugs for non-approved uses; it suppressed scientific studies that didn't suit (for example over the heart attack risks of its diabetes drug Avandia), and over-hyped others that did. It also hosted outings for doctors in exotic locations and showered them with perks, knowing that this would boost prescriptions of its drugs. I'm incensed. Not because this vindicates a conviction that pharmaceutical companies are staffed by profit-hungry liars and cheats, but precisely because I know that they are not: that so many of their scientists, and doubtless executives and marketers too, are decent folk motivated by the wish to benefit the world. They have been degraded. It is precisely because Big Pharma really has benefited the world – making life a great deal more tolerable and advancing scientific understanding – that the industry has acquired the social capital of public trust GSK has been busy squandering. But it's time we accepted that it is a business like any other, and does not operate on a higher, more altruistic plane than other multinationals. It will do whatever it can get away with, whether that means redacting scientific reports, bribing academics and physicians, or pushing into "grey" markets without proper consent or precaution. After all, this has happened before. All the giants – AstraZeneca, Bristol-Myers Squibb, Merck, Eli Lilly, Pfizer – have been investigated for bribery. One of the most notorious episodes of misconduct involved Merck's anti-inflammatory drug Vioxx, withdrawn in 2004 after the company persistently played down its risk of causing cardiovascular problems. History suggests that GSK's chief executive Andrew Witty's assurances that lessons have been learnt are meaningless. As with the banking scandals, GSK's downfall is partly a failure of management – those at the top (some of the malpractice predates Witty's incumbency) weren't watching. It's partly a failure of culture: the jollies and bribes came to seem normal, ethically unproblematic, even an entitlement, to both the donors and recipients. And it's partly a failure of regulation. The US Food and Drugs Administration has seemed at times not just toothless but actually collusive. Meanwhile, some American academics, having enjoyed Big Pharma's kickbacks for decades, are now shrieking about the Physician Payments Sunshine Act – a part of the ObamaCare package that would make it mandatory for physicians to declare any perks or payments received from drug companies greater than $10, whether as speaker fees, theatre tickets or Hawaiian holidays. The protesters claim they will drown in bureaucracy. Harvard physician Thomas Stossel claimed in the Wall Street Journal that the backhanders don't harm patients. The GSK ruling shows otherwise. In reality they will be forced to reveal how much these things supplement their already healthy income. But the problems are still deeper. You don't have to be an anti-capitalist to admit the inadequacies of relying solely on market forces for our drugs – not least for those that, being urgently needed mostly by poor countries, will never turn a profit. Incentives for Global Health, a non-profit organisation at Yale University, has argued the case for a global, public sector drug development agency, funded for example by a Tobin tax. In the unlikely event that our leaders should dare to demand such genuine recompense for the moral bankruptcy of the financial world, there would be few better uses for it – and freedom from the corrupting influence of the profit margin adds another argument to this already compelling case. One way or another, some rethinking of how drugs are discovered, developed, sold and used is needed, before the noble art of medicine comes to look more like Mr Wormwood selling a dodgy motor for whatever he can get away with.   

Big Pharma is in big trouble – or at least it should be  By DR ROBERT LEFEVER PUBLISHED: 10:00 GMT, 11 July 2012 | UPDATED: 12:57 GMT, 11 July 2012 Unprincipled: The drugs giant has been fined a record amount for offenses that often seem close to bribing doctors to use their products Two pharmaceutical giants – GlaxoSmithKline and Roche - have serious questions to answer as a result of investigations by The Medicines and Healthcare Products Regulatory Agency (MHRA).

GSK has been fined £2bn in the USA for activities that include the following:

- giving doctors free trips,

- giving a medically qualified host of a radio show £150,000 to promote one of its antidepressants for uses other than for those for which it is approved,

- paying for articles to appear in reputable medical journals when they support the use of their drugs,

- encouraging the prescription of an antidepressant drug, Paxil (marketed in the UK as Seroxat) to children even though trials by the MHRA showed that children and teenagers given this drug were significantly more likely to have suicidal thoughts. Roche has been called to account for 15,000 deaths and 65,000 adverse drug reaction reports not being forwarded from its USA subsidiary, Genentech, to Roche’s drug safety team. PETER HITCHENS: They sold us 'happy pills' - but all we got was suicide and misery GlaxoSmithKline to pay $3billion fine after pleading guilty to healthcare fraud - the biggest in U.S. history So far no direct link has been established between the use of Roche’s drugs and the deaths and side-effects. Roche themselves say, “The non-assessment and non-reporting of these adverse events was not intentional and we are taking comprehensive steps necessary to address the findings of the MHRA inspection”.

Landmark: GlaxoSmithKline Plc has agreed to plead guilty to criminal charges and pay $3billion to settle the largest case of healthcare fraud in U.S. history Big Pharma is big business – massively big business. Mistakes can occur in any business; the bigger the business the bigger the implications of the mistakes. Roche may have made a simple mistake but how on earth could a mistake of that particular nature be made? Something is definitely wrong in their management and monitoring systems. GSK are not able to say that the activities for which they were fined were anything other than deliberate. And, if this is the behaviour of two of the giants in the industry, what is likely to be the behaviour of the others? Is it just coincidence that these two companies were caught out, in one way or another, by the MHRA or is this behaviour typical of all major pharmaceutical companies? Over many decades, the pharmaceutical companies have made magnificent strides in helping doctors to treat patients more effectively. Anaesthetics, antibiotics, hormonal treatments, mono-clonal antibody treatments and many miracles of modern science have transformed lives We need to remember these wonderful benefits when the pharmaceutical companies