E-DRUG: Glaxo to pay $3 bn for largest health care fraud in US (2)
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[Morris provides his take on the recent settlement and what it means for oversight of drug promotion and invites comments from fellow E-Druggers]
Dear e-druggers,
This week started with a landmark news that GlaxoSmithKline (GSK) is to pay $3bn (£1.9bn) which is the largest healthcare fraud settlement in US history. This settlement will cover criminal fines as well as civil settlements with the federal and state governments regarding concerns about promotion of three out of nine products of GSK investigated over period of 1997 to 2004. The response and cooperation of GSK in this case is commendable and shows real commitment to consumer health. This record settlement raises key questions on the level of influence drug promotion has on prescribing patterns, the consumer protection interest of Pharma companies and the safety levels being taken care of by the Drug Regulatory Agencies (DRAs) especially in developing countries.
This case raises so many questions including:
1) How are the DRAs in developing country positioned to manage a situation of such magnitude without influence?
2) Do our consumer protection agencies and watchdogs have clear understanding of the level of harm this could cause especially in cases of medicines with narrow therapeutic windows?
3) Isn't it time to raise the bar for ethical practice in pharmaceutical products promotion?
You can add your thoughts and questions to this. This is probably a tip of the iceberg as we await many unearthed problems with other pharmaceutical companies.
Regards,
Morris OKUMU
Pharmaceutical Society of Uganda
Tuffnell Drive, Kamwokya
P. O. Box 3774; Kampala, UGANDA
E-DRUG: Glaxo to pay $3 bn for largest health care fraud in US (5)
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Dear All
I don't understand how Morris concludes that Glaxo's response and
cooperation should be praised. Glaxo withheld critical drug safety
information from drug regulators, misleading the regulators, doctors, and
patients and ultimately putting patients at risk. In addition, it
ruthlessly promoted its medicines for off-label use, again imposing grave
health threats on adolescents and other patients. Moreover, Glaxo did not
provide incriminating information willingly - it was subject to a criminal
and civil investigation from US officials. A cover-up would have landed
it in even hotter water. Glaxo's "response", fundamentally, was to have
been forced to disgorge tainted profits and to admit its civil and
criminal liability. Although governments and payers will be reimbursed,
this sanction does not directly redress the harms that patients suffered.
So, Morris' main point that drug regulators need greater power and
international forms of cooperation to deal with illegal drug promotion and
non-disclosure of important clinical information is exactly correct.
Company after company has paid after-the-fact fines for all to real harms
done to regulators, insurers, and patients. Some have suggested that real
deterrence won't happen until some pharmaceutical executives start going
to jail. Moreover, fines are not currently big enough - the fines
shouldn't just recoup tainted profits, they should go at the bottom line -
in other words be truly punitive instead of merely remedial. Similarly,
other countries should adopt procedures that allow their governments and
payers to similar impose fines and impose other penalties. I hope others
on this list can lengthen and strengthen this preliminary list of
suggestions.
Brook
Professor Brook K. Baker
Health GAP (Global Access Project)
Northeastern U. School of Law
Program on Human Rights and the Global Economy
400 Huntington Ave.
Boston, MA 02115 USA
Honorary Research Fellow, University of KwaZulu Natal, Durban, S. Africa
(w) 617-373-3217
(cell) 617-259-0760
(fax) 617-373-5056
b.baker@neu.edu
E-DRUG: Glaxo to pay $3 bn for largest health care fraud in US (6)
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Dear E-Druggers
I was director of public policy at SmithKline prior to the merger with Glaxo. Late in my career, J.P. Garnier was in charge, and his attitude was summed up simply: we shouldn't break the law, "but we shouldn't be stupid." Everyone knew he expected us to go right to the line if money were to be made, and many of us were appalled. That policy led directly to the $3 billion fine.
What didn't happen is that no individual paid a dime out of his own pocket for this misguided policy. Dr. Garnier was in fact given several million dollars as a retirement bonus. Until corporate executives share actual responsibility for their mistakes as well as their successes, real progress cannot be made.
James Russo
[Please supply affiliation when posting - moderator]
jbrusso@aol.com
E-DRUG: Glaxo to pay $3 bn for largest health care fraud in US (8)
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Dear All
I strongly support the need for punitive action. At the very least, this
represents a human rights abuse - surely this is a contravention of
international human rights codes? Another significant issue is the extent
to which this has undermined public confidence in evidence based medicine,
and, more importantly, the health care providers who prescribe and dispense
these products. They are the safety gate keepers of the community and
incidents like this raise questions about professional reputations.
Billy Futter
Emeritus Associate Professor
Rhodes University