Dear all,
I'm a long-time reader, but first-time contributor to this list. This is another case to add to the long list of bad things that _some_ pharma companies can do when they are more concerned about profits rather than ethics and society. I used to be on Australia's Medicines Australia's (the industry organisation for "big pharma") Code of Conduct Monitoring Committee and I've seen small "discrepancies" that companies try to get away with - anything from claims with no evidence to funding Mediterranean cruises for doctors. I agree with some of the other contributors that we shouldn't lump all companies together as being as bad as this case, as I've seen many great examples of how pharma provides patients, the public, and healthcare staff with important information and services that publicly-funded institutions (and government) cannot provide. But cases like the ones discussed in this list remind me of the bad things that Marcia Angell talked about in her 2004 book "The Truth About the Drug Companies".
In terms of providing data in some regulator- or publicly-accessible space, I believe some national clinical trials registries have suggested this before, but the actual way this would work still needs to be fleshed out. (Disclosure: I collaborate with the Australian and New Zealand Clinical Trials Registry)
A final comment - in this age of science commercialisation and spin-offs/start-ups, I think some companies have been leaning too far towards the financial sector's "quick profits - big profits" model of business. Medicine/science/evidence takes time to do properly. When we rush the science, we endanger patients and society. When we rush trying to sell the medical treatments, we become unethical. Just an observation. Not sure if it's an original observation though?
Regards,
Henry KO.
Henry Ko | Analyst, Centre for Health Services Research | SingHealth
Address: 168 Jalan Bukit Merah, #06-08, Tower 3, Singapore, 150168
DID: (65) 6377-8676 | Fax: (65) 6270-9667 | Mobile: (65) 9731-1574
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-----Original Message-----
From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of EVIDENCE-BASED-HEALTH automatic digest system
Sent: 04 July, 2012 7:00 AM
To: [log in to unmask]
Subject: EVIDENCE-BASED-HEALTH Digest - 3 Jul 2012 (#2012-165)
There are 7 messages totaling 3063 lines in this issue.
Topics of the day:
1. GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US
history (6)
2. Editorial by Greenhalgh
----------------------------------------------------------------------
Date: Tue, 3 Jul 2012 09:24:11 -0700
From: Paul Elias <[log in to unmask]>
Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
and the use of medications to children when they were not authorized to do so.
Best,
Paul E. Alexander
--- On Tue, 7/3/12, Ash Paul <[log in to unmask]> wrote:
From: Ash Paul <[log in to unmask]>
Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
To: [log in to unmask]
Received: Tuesday, July 3, 2012, 4:18 PM
Dear Richard,
Every believer in evidenced-based medicine should read the full judgment (link to it given right at the bottom of this email), it's incredible and it makes me seriously wonder whether the pharmaceutical industry is just as bad as the banking industry today, and whether we can trust it at all.
I quote a single line from the judgment proper:
"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," said US attorney Carmin Ortiz.
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Monday, July 2, 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
Global health care 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 U.S. 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 U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court.
GSK will also pay $2 billion to resolve its civil liabilities with the federal government under the False Claims Act, as well as the states. The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.
“Today’s multi-billion dollar settlement is unprecedented in both size and scope. It underscores the Administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud,” said James M. Cole, Deputy Attorney General. “At every level, we are determined to stop practices that jeopardize patients’ health, harm taxpayers, and violate the public trust – and this historic action is a clear warning to any company that chooses to break the law.”
“Today’s historic settlement is a major milestone in our efforts to stamp out health care fraud,” said Bill Corr, Deputy Secretary of the Department of Health and Human Services (HHS). “For a long time, our health care system had been a target for cheaters who thought they could make an easy profit at the expense of public safety, taxpayers, and the millions of Americans who depend on programs like Medicare and Medicaid. But thanks to strong enforcement actions like those we have announced today, that equation is rapidly changing.”
This resolution marks the culmination of an extensive investigation by special agents from HHS-OIG, FDA and FBI, along with law enforcement partners across the federal government. Moving forward, GSK will be subject to stringent requirements under its corporate integrity agreement with HHS-OIG; this agreement is designed to increase accountability and transparency and prevent future fraud and abuse. Effective law enforcement partnerships and fraud prevention are hallmarks of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaboration to fight fraud.
Criminal Plea Agreement
Under the provisions of the Food, Drug and Cosmetic Act, a company in its application to the FDA must specify each intended use of a drug. After the FDA approves the product as safe and effective for a specified use, a company’s promotional activities must be limited to the intended uses that FDA approved. In fact, promotion by the manufacturer for other uses – known as “off-label uses” – renders the product “misbranded.”
Paxil: In the criminal information, the government alleges that, from April 1998 to August 2003, GSK unlawfully promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use. The United States alleges that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. At the same time, the United States alleges, GSK did not make available data from two other studies in which Paxil also failed to demonstrate
efficacy in treating depression in patients under 18. The United States further alleges that GSK sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended. Since 2004, Paxil, like other antidepressants, included on its label a “black box warning” stating that antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18. GSK agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.
Wellbutrin: The United States also alleges that, from January 1999 to December 2003, GSK promoted Wellbutrin, approved at that time only for Major Depressive Disorder, for weight loss, the treatment of sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder, among other off-label uses. 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. GSK has agreed to plead guilty to misbranding Wellbutrin in that its labeling did not
bear adequate directions for these off-label uses. For the Paxil and Wellbutrin misbranding offenses, GSK has agreed to pay a criminal fine and forfeiture of $757,387,200.
Avandia: The United States alleges that, between 2001 and 2007, GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends. The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia. Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of (1) congestive heart failure,
and (2) myocardial infarction (heart attack). GSK has agreed to plead guilty to failing to report data to the FDA and has agreed to pay a criminal fine in the amount of $242,612,800 for its unlawful conduct concerning Avandia.
“This case demonstrates our continuing commitment to ensuring that the messages provided by drug manufacturers to physicians and patients are true and accurate and that decisions as to what drugs are prescribed to sick patients are based on best medical judgments, not false and misleading claims or improper financial inducements,” said Carmen Ortiz, U.S. Attorney for the District of Massachusetts.
“Patients rely on their physicians to prescribe the drugs they need,” said John Walsh, U.S. Attorney for Colorado. “The pharmaceutical industries’ drive for profits can distort the information provided to physicians concerning drugs. This case will help to ensure that your physician will make prescribing decisions based on good science and not on misinformation, money or favors provided by the pharmaceutical industry.”
Civil Settlement Agreement
As part of this global resolution, GSK has agreed to resolve its civil liability for the following alleged conduct: (1) promoting the drugs Paxil, Wellbutrin, Advair, Lamictal and Zofran for off-label, non-covered uses and paying kickbacks to physicians to prescribe those drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex; (2) making false and misleading statements concerning the safety of Avandia; and (3) reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program.
Off-Label Promotion and Kickbacks: The civil settlement resolves claims set forth in a complaint filed by the United States alleging that, in addition to promoting the drugs Paxil and Wellbutrin for unapproved, non-covered uses, GSK also promoted its asthma drug, Advair, for first-line therapy for mild asthma patients even though it was not approved or medically appropriate under these circumstances. GSK also promoted Advair for chronic obstructive pulmonary disease with misleading claims as to the relevant treatment guidelines. The civil settlement also resolves allegations that GSK promoted Lamictal, an anti-epileptic medication, for off-label, non-covered psychiatric uses, neuropathic pain and pain management. It further
resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women. It also includes allegations that GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs as well as the drugs Imitrex, Lotronex, Flovent and Valtrex. The United States alleges that this conduct caused false claims to be submitted to federal health care programs.
GSK has agreed to pay $1.043 billion relating to false claims arising from this alleged conduct. The federal share of this settlement is $832 million and the state share is $210 million.
This off-label civil settlement resolves four lawsuits pending in federal court in the District of Massachusetts under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery.
Avandia: In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile, causing false claims to be submitted to federal health care programs. Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks. GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia. The federal
share of this settlement is $508 million and the state share is $149 million.
Price Reporting: GSK is also resolving allegations that, between 1994 and 2003, GSK and its corporate predecessors reported false drug prices, which resulted in GSK’s underpaying rebates owed under the Medicaid Drug Rebate Program. By law, GSK was required to report the lowest, or “best” price that it charged its customers and to pay quarterly rebates to the states based on those reported prices. When drugs are sold to purchasers in contingent arrangements known as “bundles,” the discounts offered for the bundled drugs must be reallocated across all products in the bundle proportionate to the dollar value of the units sold. The United States alleges that GSK had bundled sales arrangements that included steep discounts known as “nominal”
pricing and yet failed to take such contingent arrangements into account when calculating and reporting its best prices to the Department of Health and Human Services. Had it done so, the effective prices on certain drugs would have been different, and, in some instances, triggered a new, lower best price than what GSK reported. As a result, GSK underpaid rebates due to Medicaid and overcharged certain Public Health Service entities for its drugs, the United States contends. GSK has agreed to pay $300 million to resolve these allegations, including $160,972,069 to the federal government, $118,792,931 to the states, and $20,235,000 to certain Public Health Service entities who paid inflated prices for the drugs at issue.
Except to the extent that GSK has agreed to plead guilty to the three-count criminal information, the claims settled by these agreements are allegations only, and there has been no determination of liability.
“This landmark settlement demonstrates the Department’s commitment to protecting the American public against illegal conduct and fraud by pharmaceutical companies,” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division. “Doctors need truthful, fair, balanced information when deciding whether the benefits of a drug outweigh its safety risks. By the same token, the FDA needs all necessary safety-related information to identify safety trends and to determine whether a drug is safe and effective. Unlawful promotion of drugs for unapproved uses and failing to report adverse drug experiences to the FDA can tip the balance of those important decisions, and the Justice Department will not tolerate attempts by those who seek to corrupt our health care system in this way.”
Non-monetary Provisions and Corporate Integrity Agreement
In addition to the criminal and civil resolutions, GSK has executed a five-year Corporate Integrity Agreement (CIA) with the Department of Health and Human Services, Office of Inspector General (HHS-OIG). The plea agreement and CIA include novel provisions that require that GSK implement and/or maintain major changes to the way it does business, including changing the way its sales force is compensated to remove compensation based on sales goals for territories, one of the driving forces behind much of the conduct at issue in this matter. Under the CIA, GSK is required to change its executive compensation program to permit the company to recoup annual bonuses and long-term incentives from covered executives if they, or their subordinates, engage in significant
misconduct. GSK may recoup monies from executives who are current employees and those who have left the company. Among other things, the CIA also requires GSK to implement and maintain transparency in its research practices and publication policies and to follow specified policies in its contracts with various health care payors.
“Our five-year integrity agreement with GlaxoSmithKline requires individual accountability of its board and executives,” said Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services. “For example, company executives may have to forfeit annual bonuses if they or their subordinates engage in significant misconduct, and sales agents are now being paid based on quality of service rather than sales targets.”
“The FDA Office of Criminal Investigations will aggressively pursue pharmaceutical companies that choose to put profits before the public’s health,” said Deborah M. Autor, Esq., Deputy Commissioner for Global Regulatory Operations and Policy, U.S. Food and Drug Administration. “We will continue to work with the Justice Department and our law enforcement counterparts to target companies that disregard the protections of the drug approval process by promoting drugs for uses when they have not been proven to be safe and effective for those uses, and that fail to report required drug safety information to the FDA.”
“The record settlement obtained by the multi-agency investigative team shows not only the importance of working with our partners, but also the importance of the public providing their knowledge of suspect schemes to the government,” said Kevin Perkins, Acting Executive Assistant Director of the FBI’s Criminal, Cyber, Response and Services Branch. “Together, we will continue to bring to justice those engaged in illegal schemes that threaten the safety of prescription drugs and other critical elements of our nation’s healthcare system.”
“ Federal employees deserve health care providers and suppliers, including drug manufacturers, that meet the highest standards of ethical and professional behavior,” said Patrick E. McFarland, Inspector General of the U.S. Office of Personnel Management. “Today’s settlement reminds the pharmaceutical industry that they must observe those standards and reflects the commitment of Federal law enforcement organizations to pursue improper and illegal conduct that places health care consumers at risk.”
“Today’s announcement illustrates the efforts of VA OIG and its law enforcement partners in ensuring the integrity of the medical care provided our nation’s veterans by the Department of Veterans Affairs,” said George J. Opfer, Inspector General of the Department of Veterans Affairs. “The monetary recoveries realized by VA in this settlement will directly benefit VA healthcare programs that provide for veterans’ continued care.”
“This settlement sends a clear message that taking advantage of federal health care programs has substantial consequences for those who try,” said Rafael A. Medina, Special Agent in Charge of the Northeast Area Office of Inspector General for the U.S. Postal Service. “The U.S. Postal Service pays more than one billion dollars a year in workers' compensation benefits and our office is committed to pursuing those individuals or entities whose fraudulent acts continue to unfairly add to that cost.”
A Multilateral Effort
The criminal case is being prosecuted by the U.S. Attorney’s Office for the District of Massachusetts and the Civil Division’s Consumer Protection Branch. The civil settlement was reached by the U.S. Attorney’s Office for the District of Massachusetts, the U.S. Attorney’s Office for the District of Colorado and the Civil Division’s Commercial Litigation Branch. Assistance was provided by the HHS Office of Counsel to the Inspector General, Office of the General Counsel-CMS Division and FDA’s Office of Chief Counsel as well as the National Association of Medicaid Fraud Control Units.
This matter was investigated by agents from the HHS-OIG; the FDA’s Office of Criminal Investigations; the Defense Criminal Investigative Service of the Department of Defense; the Office of the Inspector General for the Office of Personnel Management; the Department of Veterans Affairs; the Department of Labor; TRICARE Program Integrity; the Office of Inspector General for the U.S. Postal Service and the FBI.
This resolution is part of the government’s emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Kathleen Sebelius, Secretary of HHS. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. Over the last three years, the department has recovered a total of more than $10.2 billion in settlements, judgments, fines, restitution, and forfeiture in health care fraud matters pursued under the False Claims Act and the Food, Drug and Cosmetic Act.
Court documents related to today’s settlement can be viewed online at www.justice.gov/opa/gsk-docs.html .
Regards,
Ash
From: "Lehman, Richard" <[log in to unmask]>
To: [log in to unmask]
Sent: Tuesday, 3 July 2012, 14:14
Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
#yiv154723973 P {margin-top:0;margin-bottom:0;}
Couldn't agree more. GSK are now trying to clean up their image by supporting the priniciple of open data sharing in the future, but firms caught doing the things they have should be made to disclose their entire retrospective research databases for independent scrutiny at their own cost, as well as being made open to the prosecution of individuals involved in fraud/false marketing/data concealment.
It is shameful that settlements like this can be part of a business plan to amass huge profits while knowingly harming patients. As yet there is nothing concrete in place to deter similar behaviour in the future.
Richard
From: Evidence based health (EBH) [[log in to unmask]] on behalf of Paul Elias [[log in to unmask]]
Sent: Tuesday, July 03, 2012 9:03 AM
To: [log in to unmask]
Subject: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
Once again, the good, the bad, the ugly about big pharma...for this, I can only see the bad and ugly, nothing good about this. this was all greed and complicity. Last week it was Pfizer and the Celebrex deceit and witholding of safety clinical data, now Glaxo...
http://ca.finance.yahoo.com/news/record-settlement-glaxosmithkline-plead-guilty-pay-3b-illicit-192857575--finance.html
Best,
Paul E. Alexander
------------------------------
Date: Tue, 3 Jul 2012 09:39:47 -0700
From: Ash Paul <[log in to unmask]>
Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
Dear Sir Iain,
Have you read the latest scandal on Roche?
This article is from the Financial Times.
You can read the associated MHRA Report on Roche at the following weblink:
June 21, 2012 10:37 pm
Roche did not report US patients’ deaths
By Andrew Jack in London
Roche failed to inform regulators of reports of illness and death in as many as 80,000 US patients who received the Swiss pharmaceuticals group’s medicines over the past 15 years.
In a report on unprecedented failures in “pharmaco-vigilance”, the UK Medicines and Healthcare Products Regulatory Agency highlighted a series of “deficiencies” at Roche.
The data could change regulators’ assessment of the risks and benefits of its medicines and lead to the withdrawal of drugs from the market or a change in the guidance to doctors.
The reports – which include 15,161 deaths of US patients – related to the full range of drugs provided by Genentech, Roche’s US subsidiary, distributed by its “patient support programme” through which it offers its products to patients who are uninsured or underinsured.
There were other failings identified by regulators with data on suspected side effects in 23,000 other patients and 600 participants in clinical trials.
Sir Kent Woods, chief executive of the regulator, said: “Roche’s actions are unacceptable and our investigation has identified that Roche’s reporting systems are inadequate.”
The Swiss company said: “Roche acknowledges it did not fully comply with regulations and appreciates the concerns that can be caused by this issue for people using its products.”
Genentech produces such cancer treatments as Avastin and Herceptin, as well as Lucentis to treat age-related macular degeneration, which causes blindness.
The European Medicines Agency, which made public the findings, cautioned: “There is at present no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or healthcare professionals to take any action.”
It said some of the suspected side effects may have been reported to regulators by others such as patients directly or their doctors.
Roche said that the data on side effects and other reports of patient health collected by the outside contractor it uses to run its support programme had not been entered into its own database and not passed on either to US or European regulators.
“This was definitely unintentional,” the company said, adding that it had initially identified problems in its reporting systems last December and all of its work re-examining the data would be completed by January next year.
Failures in Roche’s manufacturing were previously highlighted in 2007 in a European regulatory inspection on its HIV drug Viracept.
Copyright The Financial Times Limited 2012.
>________________________________
>From: Iain Chalmers <[log in to unmask]>
>To: [log in to unmask]; "Lehman, Richard" <[log in to unmask]>; [log in to unmask]
>Sent: Tuesday, 3 July 2012, 16:26
>Subject: RE: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
>
>I actually feel very sorry that the current management of GSK is having to field the consequences of the appalling, greedy actions taken under the previous CEO – Jean Pierre Garnier. In several ways since Garnier’s departure, GSK has actually been ahead of the rest of the industry in committing to openness. See Tom Jefferson’s contrast between the way that GSK responded to a request for data on neuraminidase inhibitors and the disgraceful way that Roche has responded. And note: the Regius Professor of Medicine in this town in on the board of Roche. Iain
>
>
>________________________________
>
>From:[log in to unmask] [mailto:[log in to unmask]] On Behalf Of Ash Paul
>Sent: 03 July 2012 16:19
>To: Lehman, Richard; [log in to unmask]; PATH Group
>Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
>
>Dear Richard,Every believer in evidenced-based medicine should read the full judgment (link to it given right at the bottom of this email), it's incredible and it makes me seriously wonder whether the pharmaceutical industry is just as bad as the banking industry today, and whether we can trust it at all.I quote a single line from the judgment proper:"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," said US attorney Carmin Ortiz.
>
http://www.ema.europa.eu/docs/en_GB
------------------------------
Date: Tue, 3 Jul 2012 12:54:46 -0400
From: Amy Price <[log in to unmask]>
Subject: Re: Editorial by Greenhalgh
I find this quote particularly onerous "On the other hand, I think something
sinister is happening, mainly because of the striking circumstantial
resonance between the reductionism of EBM and the reductionism of
contemporary policymaking". How is this not a slap in the face? I as a
newly minted EBHC student have already been forced to justify by several as
if this was a done deal and we are no better than Pharma and their 3b
fiasco. People understand this to mean that we are using EBM to rob people
of their healthcare rights. Junk science medics are saying see we are free,
people that practice EBM are bought and paid for bean counters. If they
challenge me, who has not challenged back, has little public exposure and is
not making any income on this how do you think this wave is going to roll
for those who have invested their research in this practice.
Everything that can be will be used to control behavior and it is good to be
aware but more importantly what constructive plans are in place to
neutralize this in tangible ways? Fanaticism is rampant in all disciplines
and is a reflection of lack of understanding and personality involved. EBHC
is not a religion it is a dynamic clinical tool to promote
understanding/discerning of quality research and clinical care
Amy
From: Michael Bennett <[log in to unmask]>
Reply-To: Michael Bennett <[log in to unmask]>
Date: Tuesday, July 3, 2012 12:21 AM
To: <[log in to unmask]>
Subject: FW: Editorial by Greenhalgh
What a fascinating editorial by TG! My apologies if I am repeating what
others have said, but I have been out of circulation for a while and may
have missed earlier comments.
To my view, she has eruditely put into words what many of us have been
trying to say for some time that the EBM paradigm must be seen in a
broader context. I see no suggestion in the editorial that we should abandon
the principles of EBM at all. What we need to do is ensure that EBM stays
the clinical tool it was originally conceived to be that is to say, a tool
for us clinicians to assist patients (see the editorial for some other
useful tools that should be integrated). TG is pointing out that allowing it
to be misconstrued/misused by non-clinicians as a means to limit the
provision of thoughtful care to patients is a situation for which many of us
may (partly and perhaps unwittingly) be to blame.
I do NOT take it as a rejection of EBM, but as a timely warning not to let
EBM become a religion. My own local and much less erudite exhortation to
colleagues has been that they had better become familiar with the language
and practice of EBM because, not only does it assist good practice, but
sooner or later bean-counters and managers are going to try and bamboozle us
by misusing EBM tools in order to control our behaviour. We need to
recognise and resist their efforts and understanding the language is
essential for that.
Mike Bennett
Sydney
From: Evidence based health (EBH)
[mailto:[log in to unmask]] On Behalf Of Amy Price
Sent: Tuesday, 3 July 2012 7:19
To: [log in to unmask]
Subject: Re: journal of primary health care and article on probabilitistic
reasoning
Dear Bruce and All,
I like your probalistic paper and they way you have tied the nomogram to
useful outcomes.
I am beyond confused by the Trish Greenhalgh paper as I am presently
enrolled in the EBHC course at Oxford and have taken 6/6 modules. There is
not one module where Dr. Greenhalgh's present concept of EBM was taught or
encouraged, quite to the contrary. In every module we are asked to consider
type 1 and 2 decision making and how clinical decisions, guidelines, how we
write reviews or design experiments or assess/design diagnostics will affect
an individual patient. We are taught that patients will not fit a set
paradigm and that our responsibility is to offer them the best care
available using the the art, the science and the practice of medicine. We
are taught to trust our instincts and equip them with the best evidence
possible. I read 'How your doctor thinks' and there is nothing in there
that we were not taught and expected to practice. In fact multiple
discussions not just lectures and books occur on every module to make sure
we get this and learn the benefits and the limitations of EBM.
I find this quote particularly onerous "On the other hand, I think something
sinister is happening, mainly because of the striking circumstantial
resonance between the reductionism of EBM and the reductionism of
contemporary policymaking". Really??? We discuss policy making too and how
reductionism can be eliminated and real science promoted and practiced. Why
not enlist us to uncover the weaknesses and improve policy rather than toss
us in the sea of blame. The blame mentality solves nothing , creative
insight and working together to solve problems does. If Dr. Greenhalgh
thinks something sinister is happening why can she not use her considerable
influence and intelligence to recruit others to solve the problem instead of
just talk about it. Where are her suggested solutions, do you think reading
4 books will fix it?
It is challenging enough to gently lead others into ways to find and apply
best evidence without unwarranted pushback from Dr. Greenhalgh. It is sad
that she would allow one overconfident student to muddy the waters for the
rest of us and define this as EBM. I really can see where she has gone wrong
though, giving 4 books to a self confirmed by the book expert is a waste of
space. He did not learn with the patient and the physician right in front of
him. He would be better sent to observe under supervision and with a gag
order chronic, terminal and desparate patients and then sent to practical
empathy classes until he is fit to practise.
Onwards and Upwards,
Amy
From: Bruce Arroll <[log in to unmask]>
Reply-To: Bruce Arroll <[log in to unmask]>
Date: Monday, July 2, 2012 3:36 PM
To: <[log in to unmask]>
Subject: journal of primary health care and article on probabilitistic
reasoning
Dear all
No doubt you have been following the vigorous debate over EBM with Trish
Greenhalgh. It was in the latest edition of the Journal of Primary Health
Care. This is a medlined journal that is interested in high quality research
and has a quick turnaround time for reviews. In it there is an article by
myself et al on probabilistic reasonsing. We think we have pictorially
linked pre-test probability with the Fagan nomogram (and post test
probability). We developed this as a tool for teaching undergraduates
although in my experience untrained graduates know little of the subject
matter (potential conflict of interest I am on the editorial board of the
JPHC)
http://www.rnzcgp.org.nz/jphc-june-2012/
http://www.rnzcgp.org.nz/assets/documents/Publications/JPHC/June-2012/JPHCVi
ewpointArrollJune2012.pdf
Bruce
Bruce Arroll MBChB, PhD, FNZCPHM, FRNZCGP
Professor and Elaine Gurr Chair in General Practice
University of Auckland
Private Bag 92019
Auckland
New Zealand
ph 64-9-9236978
fax 64-9-3737624
email [log in to unmask]
Physical address
School of Population Health room 378 building 730
Tamaki Campus
Corner Morrins and Merton Rd
Glen Innes
Auckland
From: Evidence based health (EBH)
[mailto:[log in to unmask]] On Behalf Of Amy Price
Sent: Sunday, 3 June 2012 4:17 p.m.
To: [log in to unmask]
Subject: Why an Evidence Based Approach
I am posting for Zbys as he got a reject from the listserve. His article
makes some excellent on target points!
Amy
Surely its more than this i.e. bad¹ research.. its also about ³More or
Less Healthcare research OR healthcare research more or less²
http://www.bahrainmedicalbulletin.com/june_2008/Editorial.pdf
Zbys Fedorowicz
Director
The Bahrain Branch of the UK Cochrane Centre
The Cochrane Collaboration
From: Evidence based health (EBH)
[mailto:[log in to unmask]] On Behalf Of Amy Price
Sent: Sunday, June 03, 2012 5:09 AM
To:[log in to unmask]
<mailto:[log in to unmask]>
Subject: Re: Why an Evidence Based Approach
I agree and a lot of 'treatment' is marketing and word of mouth. If it works
it will work consistently blinded and with controls. Anecedotes and
experience are more fun and approachable than math and objectivity. The only
reason I went in this field was because `I wanted true pictures for this I
will even do the math even though I am no whiz. If people are not willing to
pay the price to do research right they need to enjoy a different field. The
price for doing resarch wrong is lives, people and money
Amy
From: Paul Elias <[log in to unmask]>
Reply-To: Paul Elias <[log in to unmask]>
Date: Saturday, June 2, 2012 9:48 PM
To: <[log in to unmask]>
Subject: Re: Why an Evidence Based Approach
because in many instances, experts are clearly wrong...its that simple. they
dont know the hell of what they are talking about and making conclusions
that policy etc are based upon and the result is often morbidity and
mortality...so some wise guy like Guyatt and Sackett and the like , maybe
not the only thinkers on this, but decided enough of this and lets formalize
and standardize the approach and put some teeth into it...people die in the
thousands due to decisions based on so called experts wracked with
credentials yet just heresay and anecdotes...is this due to the treatment or
intervention or due to chance? to answer this, one needs an evidence based
controlled systematic approach. yes, and large sample sizes and
randomization to spread around potential confoudners and competing
explanations...there remains so much uncertainty in all forms of research
and inquiry...so many possible explanations...so we need to control or
mitigate the uncertainty and at the least, quantify it and account for it in
an evidence based approach.
my 2 cents...
Best,
Paul E. Alexander
--- On Sat, 6/2/12, Anoop Balachandran <[log in to unmask]> wrote:
From: Anoop Balachandran <[log in to unmask]>
Subject: Why an Evidence Based Approach
To: [log in to unmask]
Received: Saturday, June 2, 2012, 11:03 PMI am trying to figure out why we
need an evidence based approach and medical statistics . Or how best to
explain it someone who is more convinced by anecdotes and personal
experiences. Or why did things like blood letting lasted for almost 2500
years.
Here are some of the major reasons I think:
1. Cognitive bias and heuristics - We easily make errors because that's how
we are designed. This could be the form confirmation bias, availibility
heuristic, representative heuristic and so forth.
2. Random Variability: Random variability is inherent in every biological
response. A few who smoked died at an early age while a few who smoked
lived till 80 or 90. The only way to figure if there is an actual difference
or if this is just due to random variation is by looking at large sample
sizes and using proper statistics.
Did I miss anything important?
Thank you so much!
------------------------------
Date: Tue, 3 Jul 2012 09:55:29 -0700
From: Paul Elias <[log in to unmask]>
Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
this is the difficulty, that good people like you get cast with the same brush...but you speak out, and separate yourself and continue doing what you do best which is good. good for the well being of people...it shines through and the reality is that the only way we can fix things and anything really, is to bring to light...uncover and open it up to scrutiny. and engage the public for they have a right to know.
Best,
Paul E. Alexander
--- On Tue, 7/3/12, Andrzej Glowinski <[log in to unmask]> wrote:
From: Andrzej Glowinski <[log in to unmask]>
Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
To: [log in to unmask]
Received: Tuesday, July 3, 2012, 4:34 PM
Although I agree with the harshest penalties for both companies and individuals responsible for these unacceptable actions, please remember that there are very many people who work or have worked -- myself included -- for pharma companies, and to whom the "ethical" in what used to be "ethical pharmaceuticals" was, and remains, primary.
It is very troubling to feel associated with people who hold the view that fraud of this kind might be acceptable. However, it is also extremely uncomfortable that some view everyone associated with pharma as evil. I and colleagues have in the past categorically refused to work with some units in some companies because of their attitudes, and made this clear, even if it meant attracting ill-feeling or turning down paid work. Probably won't make much difference, but at least my conscience is clear.
And yes, my small pension will be affected by all of this.
I hope that "these folk" refers specifically to those directly responsible.
Andrzej Glowinski
On 3 Jul 2012, at 15:21, Tom Jefferson wrote:
The only deterrent for these folk are jail and confiscation of bank accounts, property and other assets including pensions.
On 3 July 2012 16:18, Penny S Reynolds/FS/VCU <[log in to unmask]> wrote:
To put the settlement into its financial perspective, Katie Smith of the New York Times stated on the PBS Newshour that the combined sales of Avandia, Paxil and Wellbutrin totaled approximately $26 billion over the settlement period. So will a $3B fine be much of a deterrent to this sort of irresponsible behaviour?
bw
Penny S Reynolds
The world presents enough problems if you believe it to be a world of law and order, do not add to them by believing it to be a world of miracles. Louis D. Brandeis
-----"Evidence based health (EBH)" <[log in to unmask]> wrote: -----
To: [log in to unmask]
From: "Lehman, Richard"
Sent by: "Evidence based health (EBH)"
Date: 07/03/2012 09:14
Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
Couldn't agree more. GSK are now trying to clean up their image by supporting the priniciple of open data sharing in the future, but firms caught doing the things they have should be made to disclose their entire retrospective research databases for independent scrutiny at their own cost, as well as being made open to the prosecution of individuals involved in fraud/false marketing/data concealment.
It is shameful that settlements like this can be part of a business plan to amass huge profits while knowingly harming patients. As yet there is nothing concrete in place to deter similar behaviour in the future.
Richard
From: Evidence based health (EBH) [[log in to unmask]] on behalf of Paul Elias [[log in to unmask]]
Sent: Tuesday, July 03, 2012 9:03 AM
To: [log in to unmask]
Subject: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
Once again, the good, the bad, the ugly about big pharma...for this, I can only see the bad and ugly, nothing good about this. this was all greed and complicity. Last week it was Pfizer and the Celebrex deceit and witholding of safety clinical data, now Glaxo...
http://ca.finance.yahoo.com/news/record-settlement-glaxosmithkline-plead-guilty-pay-3b-illicit-192857575--finance.html
Best,
Paul E. Alexander
--
Dr Tom Jefferson
www.attentiallebufale.it
------------------------------
Date: Tue, 3 Jul 2012 13:33:21 -0400
From: Amy Price <[log in to unmask]>
Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
Hilda
Is not this what HHS requires anyway? They will just be
scrutinised/profiled more closely. It is almost never invoked but anything
involving public trust does make individual board members liable at least
civil level. Could be I have this wrong (I am no lawyer) but it was
heavily discussed in regards to a recent IND
Best
Amy
On 7/3/12 11:28 AM, "Bastian, Hilda (NIH/NLM/NCBI) [C]"
<[log in to unmask]> wrote:
>It wasn't only a civil fine with money being the only deterrent. It was
>also partly a fine for criminal offence, with additional consequences
>meant to be a deterrent for the next five years:
>
>"Moving forward, GSK will be subject to stringent requirements under its
>corporate integrity agreement with HHS-OIG; this agreement is designed to
>increase accountability and transparency and prevent future fraud and
>abuse.
>³Our five-year integrity agreement with GlaxoSmithKline requires
>individual accountability of its board and executives,² said Daniel R.
>Levinson, Inspector General of the U.S. Department of Health and Human
>Services. ³For example, company executives may have to forfeit annual
>bonuses if they or their subordinates engage in significant misconduct,
>and sales agents are now being paid based on quality of service rather
>than sales targets.²
>
>
>
>
>
>
>
>
>
>
>http://www.justice.gov/opa/pr/2012/July/12-civ-842.html
>
>Hilda
>
>
>From: <Poses>, Roy <[log in to unmask]<mailto:[log in to unmask]>>
>Reply-To: "Poses, Roy" <[log in to unmask]<mailto:[log in to unmask]>>
>To:
>"[log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAI
>L.AC.UK>"
><[log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAI
>L.AC.UK>>
>Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud
>settlement in US history
>
>Remember that the $3 billion payment is delayed many years since the
>events that generated it, and hence discounted.
>
>Remember that the $3 billion will come ultimately from all stock holders,
>all employees, and from customers (patients) and tax-payers.
>
>The money will not come from the people who most benefited from the
>various scams in question, in particular the top executives whose
>bonuses, stock options, etc were driven by the short-term revenue
>generated, and their cronies and helpers in marketing, PR, etc. Also, so
>far the money will not come from the academics and health care
>professionals who took money from GSK as key opinion leaders,
>"investigators" of the corrupted studies, etc, and from the university
>leaders whose compensation was boosted by the grants they brought in.
>
>As long as no individuals suffer any major negative consequences, do not
>expect even a $3 billion settlement to deter future bad behavior.
>
>As Charles Ferguson said when he accepted the Oscar for "Inside Job," no
>one has gone to jail (then referring to the US finance sector).
>
>See on Health Care Renewal:
>
>http://hcrenewal.blogspot.com/search/label/legal%20settlements
>
>http://hcrenewal.blogspot.com/search/label/executive%20compensation
>
>On Tue, Jul 3, 2012 at 10:30 AM, Klim McPherson
><[log in to unmask]<mailto:[log in to unmask]>>
>wrote:
>It looks like $3B might have been most of the profit though. And their
>days as free agents of callous exploitation are surely numbered bankers
>too?
>
>Klim
>
>
>Klim McPherson MA Phd FFPH FMedSci
>Visiting Professor of Public Health Epidemiology
>Nuffield Dept Obstetrics & Gynaecology
>Emeritus Fellow of New College
>University of Oxford
>Mobile 07711335993
>
>
>
>
>
>From: Tom Jefferson
><[log in to unmask]<mailto:[log in to unmask]>>
>Reply-To: Tom Jefferson
><[log in to unmask]<mailto:[log in to unmask]>>
>Date: Tuesday, 3 July 2012 15:21
>To:
>"[log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAI
>L.AC.UK>"
><[log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAI
>L.AC.UK>>
>
>Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud
>settlement in US history
>
>The only deterrent for these folk are jail and confiscation of bank
>accounts, property and other assets including pensions.
>
>On 3 July 2012 16:18, Penny S Reynolds/FS/VCU
><[log in to unmask]<mailto:[log in to unmask]>> wrote:
>To put the settlement into its financial perspective, Katie Smith of the
>New York Times stated on thePBS Newshour that the combined sales of
>Avandia, Paxil and Wellbutrin totaled approximately $26 billion over the
>settlement period. So will a $3B fine be much of a deterrent to this
>sort of irresponsible behaviour?
>
>
>
>
>
>bw
>Penny S Reynolds
>
>The world presents enough problems if you believe it to be a world of law
>and order, do not add to them by believing it to be a world of miracles.
>Louis D. Brandeis
>
>-----"Evidence based health (EBH)"
><[log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAI
>L.AC.UK>> wrote: -----
>To:
>[log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAIL
>.AC.UK>
>From: "Lehman, Richard"
>Sent by: "Evidence based health (EBH)"
>Date: 07/03/2012 09:14
>Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud
>settlement in US history
>
>
>Couldn't agree more. GSK are now trying to clean up their image by
>supporting the priniciple of open data sharing in the future, but firms
>caught doing the things they have should be made to disclose their entire
>retrospective research databases for independent scrutiny at their own
>cost, as well as being made open to the prosecution of individuals
>involved in fraud/false marketing/data concealment.
>
>It is shameful that settlements like this can be part of a business plan
>to amass huge profits while knowingly harming patients. As yet there is
>nothing concrete in place to deter similar behaviour in the future.
>
>Richard
>________________________________
>From: Evidence based health (EBH)
>[[log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAI
>L.AC.UK>] on behalf of Paul Elias
>[[log in to unmask]<mailto:[log in to unmask]>]
>Sent: Tuesday, July 03, 2012 9:03 AM
>To:
>[log in to unmask]<mailto:EVIDENCE-BASED-HEALTH@JISCMAIL
>.AC.UK>
>Subject: GlaxoSmithKline to pay $3B in largest healthcare fraud
>settlement in US history
>
>Once again, the good, the bad, the ugly about big pharma...for this, I
>can only see the bad and ugly, nothing good about this. this was all
>greed and complicity. Last week it was Pfizer and the Celebrex deceit and
>witholding of safety clinical data, now Glaxo...
>
>
>
>
>http://ca.finance.yahoo.com/news/record-settlement-glaxosmithkline-plead-g
>uilty-pay-3b-illicit-192857575--finance.html
>
>
>Best,
>
>Paul E. Alexander
>
>
>
>
>
>
>
>
>--
>Dr Tom Jefferson
>www.attentiallebufale.it<http://www.attentiallebufale.it>
>
>
>
>
>--
>Roy M. Poses MD FACP
>President
>Foundation for Integrity and Responsibility in Medicine (FIRM)
>[log in to unmask]<mailto:[log in to unmask]>
>Clinical Associate Professor of Medicine
>Alpert Medical School, Brown University
>[log in to unmask]<mailto:[log in to unmask]>
>
------------------------------
Date: Tue, 3 Jul 2012 13:36:17 -0400
From: Amy Price <[log in to unmask]>
Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
Andrzej, I couldn't agree more, tarring all with the same brush just starts
a feeding frenzy and also even for this company I am sure there are those on
the sidelines that were contracted and acted in integrity for their part of
the assignment
Amy
From: Andrzej Glowinski <[log in to unmask]>
Reply-To: Andrzej Glowinski <[log in to unmask]>
Date: Tuesday, July 3, 2012 11:34 AM
To: <[log in to unmask]>
Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud
settlement in US history
Although I agree with the harshest penalties for both companies and
individuals responsible for these unacceptable actions, please remember that
there are very many people who work or have worked -- myself included -- for
pharma companies, and to whom the "ethical" in what used to be "ethical
pharmaceuticals" was, and remains, primary.
It is very troubling to feel associated with people who hold the view that
fraud of this kind might be acceptable. However, it is also extremely
uncomfortable that some view everyone associated with pharma as evil. I and
colleagues have in the past categorically refused to work with some units in
some companies because of their attitudes, and made this clear, even if it
meant attracting ill-feeling or turning down paid work. Probably won't make
much difference, but at least my conscience is clear.
And yes, my small pension will be affected by all of this.
I hope that "these folk" refers specifically to those directly responsible.
Andrzej Glowinski
On 3 Jul 2012, at 15:21, Tom Jefferson wrote:
> The only deterrent for these folk are jail and confiscation of bank accounts,
> property and other assets including pensions.
>
> On 3 July 2012 16:18, Penny S Reynolds/FS/VCU <[log in to unmask]> wrote:
>> To put the settlement into its financial perspective, Katie Smith of the New
>> York Times stated on the PBS Newshour that the combined sales of Avandia,
>> Paxil and Wellbutrin totaled approximately $26 billion over the settlement
>> period. So will a $3B fine be much of a deterrent to this sort of
>> irresponsible behaviour?
>>
>>
>> bw
>> Penny S Reynolds
>>
>> The world presents enough problems if you believe it to be a world of law and
>> order, do not add to them by believing it to be a world of miracles. Louis D.
>> Brandeis
>>
>> -----"Evidence based health (EBH)" <[log in to unmask]>
>> wrote: -----
>>> To: [log in to unmask]
>>> From: "Lehman, Richard"
>>> Sent by: "Evidence based health (EBH)"
>>> Date: 07/03/2012 09:14
>>> Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud
>>> settlement in US history
>>>
>>>
>>> Couldn't agree more. GSK are now trying to clean up their image by
>>> supporting the priniciple of open data sharing in the future, but firms
>>> caught doing the things they have should be made to disclose their entire
>>> retrospective research databases for independent scrutiny at their own cost,
>>> as well as being made open to the prosecution of individuals involved in
>>> fraud/false marketing/data concealment.
>>>
>>> It is shameful that settlements like this can be part of a business plan to
>>> amass huge profits while knowingly harming patients. As yet there is nothing
>>> concrete in place to deter similar behaviour in the future.
>>>
>>> Richard
>>>
>>> From: Evidence based health (EBH) [[log in to unmask]] on
>>> behalf of Paul Elias [[log in to unmask]]
>>> Sent: Tuesday, July 03, 2012 9:03 AM
>>> To: [log in to unmask]
>>> Subject: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement
>>> in US history
>>>
>>> Once again, the good, the bad, the ugly about big pharma...for this, I can
>>> only see the bad and ugly, nothing good about this. this was all greed and
>>> complicity. Last week it was Pfizer and the Celebrex deceit and witholding
>>> of safety clinical data, now Glaxo...
>>>
>>>
>>>
>>>
>>> http://ca.finance.yahoo.com/news/record-settlement-glaxosmithkline-plead-gui
>>> lty-pay-3b-illicit-192857575--finance.html
>>>
>>>
>>> Best,
>>>
>>> Paul E. Alexander
>>>
>>>
>>>
>>>
>>>>
>
>
>
> --
> Dr Tom Jefferson
> www.attentiallebufale.it <http://www.attentiallebufale.it/>
>
------------------------------
Date: Tue, 3 Jul 2012 13:40:15 -0400
From: Jim Walker <[log in to unmask]>
Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement in US history
Granting that the handsome salaries paid across those companies are funded in some part by the profits from the embarrassing activities.
Jim
James M. Walker, MD, FACP
Chief Medical Information Officer
Geisinger Health System
The best way to predict the future is to invent it.
- Alan Kay
>>> Amy Price <[log in to unmask]> 7/3/2012 1:36 PM >>>
Andrzej, I couldn't agree more, tarring all with the same brush just starts
a feeding frenzy and also even for this company I am sure there are those on
the sidelines that were contracted and acted in integrity for their part of
the assignment
Amy
From: Andrzej Glowinski <[log in to unmask]>
Reply-To: Andrzej Glowinski <[log in to unmask]>
Date: Tuesday, July 3, 2012 11:34 AM
To: <[log in to unmask]>
Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud
settlement in US history
Although I agree with the harshest penalties for both companies and
individuals responsible for these unacceptable actions, please remember that
there are very many people who work or have worked -- myself included -- for
pharma companies, and to whom the "ethical" in what used to be "ethical
pharmaceuticals" was, and remains, primary.
It is very troubling to feel associated with people who hold the view that
fraud of this kind might be acceptable. However, it is also extremely
uncomfortable that some view everyone associated with pharma as evil. I and
colleagues have in the past categorically refused to work with some units in
some companies because of their attitudes, and made this clear, even if it
meant attracting ill-feeling or turning down paid work. Probably won't make
much difference, but at least my conscience is clear.
And yes, my small pension will be affected by all of this.
I hope that "these folk" refers specifically to those directly responsible.
Andrzej Glowinski
On 3 Jul 2012, at 15:21, Tom Jefferson wrote:
> The only deterrent for these folk are jail and confiscation of bank accounts,
> property and other assets including pensions.
>
> On 3 July 2012 16:18, Penny S Reynolds/FS/VCU <[log in to unmask]> wrote:
>> To put the settlement into its financial perspective, Katie Smith of the New
>> York Times stated on the PBS Newshour that the combined sales of Avandia,
>> Paxil and Wellbutrin totaled approximately $26 billion over the settlement
>> period. So will a $3B fine be much of a deterrent to this sort of
>> irresponsible behaviour?
>>
>>
>> bw
>> Penny S Reynolds
>>
>> The world presents enough problems if you believe it to be a world of law and
>> order, do not add to them by believing it to be a world of miracles. Louis D.
>> Brandeis
>>
>> -----"Evidence based health (EBH)" <[log in to unmask]>
>> wrote: -----
>>> To: [log in to unmask]
>>> From: "Lehman, Richard"
>>> Sent by: "Evidence based health (EBH)"
>>> Date: 07/03/2012 09:14
>>> Subject: Re: GlaxoSmithKline to pay $3B in largest healthcare fraud
>>> settlement in US history
>>>
>>>
>>> Couldn't agree more. GSK are now trying to clean up their image by
>>> supporting the priniciple of open data sharing in the future, but firms
>>> caught doing the things they have should be made to disclose their entire
>>> retrospective research databases for independent scrutiny at their own cost,
>>> as well as being made open to the prosecution of individuals involved in
>>> fraud/false marketing/data concealment.
>>>
>>> It is shameful that settlements like this can be part of a business plan to
>>> amass huge profits while knowingly harming patients. As yet there is nothing
>>> concrete in place to deter similar behaviour in the future.
>>>
>>> Richard
>>>
>>> From: Evidence based health (EBH) [[log in to unmask]] on
>>> behalf of Paul Elias [[log in to unmask]]
>>> Sent: Tuesday, July 03, 2012 9:03 AM
>>> To: [log in to unmask]
>>> Subject: GlaxoSmithKline to pay $3B in largest healthcare fraud settlement
>>> in US history
>>>
>>> Once again, the good, the bad, the ugly about big pharma...for this, I can
>>> only see the bad and ugly, nothing good about this. this was all greed and
>>> complicity. Last week it was Pfizer and the Celebrex deceit and witholding
>>> of safety clinical data, now Glaxo...
>>>
>>>
>>>
>>>
>>> http://ca.finance.yahoo.com/news/record-settlement-glaxosmithkline-plead-gui
>>> lty-pay-3b-illicit-192857575--finance.html
>>>
>>>
>>> Best,
>>>
>>> Paul E. Alexander
>>>
>>>
>>>
>>>
>>>>
>
>
>
> --
> Dr Tom Jefferson
> www.attentiallebufale.it <http://www.attentiallebufale.it/>
>
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