MESSAGE
| DATE | 2017-06-11 |
| FROM | Ruben Safir
|
| SUBJECT | Re: [Hangout - NYLXS] Abbott Scam
|
On 06/11/2017 02:09 AM, Ruben Safir wrote:
> On 06/11/2017 01:58 AM, Ruben Safir wrote:
>> On Sat, Jun 10, 2017 at 08:15:37PM -0700, Rick Moen wrote:
>>> Quoting Ruben Safir (ruben-at-mrbrklyn.com):
>>>
>>>> Abbott Pharmacuetics is giving kickback to healthcare insurance
>>>> companies to mandate that Pharmacies must use their lifestyle diabetic
>>>> testing supplies. This is thanks to Obama care.
>>>
>>> If Abbott Pharmaceuticals is engaging in corruption, it should get
>>> prosecuted for that. Please provide your evidence to both this mailing
>>> list and state prosecutors. Thank you.
>>>
>
> It is fucking corrupt to give insurance companies kickbacks and then
> shake down healthcare providers, mostly pharmacists, so that they have
> to pay you for the privileged to provide healthcare for patients.
>
> You don't know a damn thing about health insurance or the scams of the
> healthcare business, of which this is one of the largest.
>
> If you say, one more time, that just because something is legal that
> it is not corruption and immoral, I'll kick you off the list and
> terminate the friendship.
>
> I've been doing healthcare for decades now and been screwed by
> this broad corruption for decades. It has destroyed a good part of my
> life, and caused enormous suffering.
>
> If you want a platform to drone on half baked legal arguments why it is
> moral for force healthcare providers to pay extortion to Abbott after
> Abbot goes about paying kickbacks to PBMs to make them the exclusive
> provider of diabetic supplies, you can do that on YOUR list.
>
> I don't care WHY you think this kind of racketeering is legal.
>
> Ruben
>
>
https://www.fda.gov/ICECI/CriminalInvestigations/ucm303539.htm
Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
May 7, 2012
United States Attorney
Office of Public Affairs
Company Maintained Specialized Sales Force to Market Drug for Off Label
Purposes; Targeted Elderly Dementia Patients in Nursing Homes
WASHINGTON - Global Health Care Company Abbott Laboratories Inc. has
pleaded guilty and agreed to pay $1.5 billion to resolve its criminal
and civil liability arising from the company's unlawful promotion of the
prescription drug Depakote for uses not approved as safe and effective
by the Food and Drug Administration (FDA), the Justice Department
announced today. The resolution - the second largest payment by a drug
company - includes a criminal fine and forfeiture totaling $700 million
and civil settlements with the federal government and the states
totaling $800 million. Abbott also will be subject to court-supervised
probation and reporting obligations for Abbott's CEO and Board of Directors.
"Today's settlement shows further evidence of our deep commitment to
public health and our determination to hold accountable those who commit
fraud," said James M. Cole, Deputy Attorney General. "We are resolute in
stopping this type of activity and today's settlement sends a strong
message to other companies."
The FDA is responsible for approving drugs as safe and effective for
specified uses. Under the Food, Drug and Cosmetic Act (FDCA), a company
in its application to the FDA must specify each intended use of a drug.
A company's promotional activities must be limited to only the intended
uses that FDA approved. In fact, promotion by the manufacturer for other
uses - known as "off-label" uses - renders the product misbranded.
Abbott has pleaded guilty to misbranding Depakote by promoting the drug
to control agitation and aggression in elderly dementia patients and to
treat schizophrenia when neither of these uses was FDA approved. In an
agreed statement of facts filed in the criminal action, Abbott admits
that from 1998 through 2006, the company maintained a specialized sales
force trained to market Depakote in nursing homes for the control of
agitation and aggression in elderly dementia patients, despite the
absence of credible scientific evidence that Depakote was safe and
effective for that use. In addition, from 2001 through 2006, the company
marketed Depakote in combination with atypical antipsychotic drugs to
treat schizophrenia, even after its clinical trials failed to
demonstrate that adding Depakote was any more effective than an atypical
antipsychotic alone for that use. Illegal Promotion of Depakote to
Control Agitation and Aggression in Dementia Patients.
The FDA approved Depakote for only three uses: epileptic seizures,
bipolar mania and the prevention of migraines. The FDA never approved
the drug as safe and effective for the off-label use of controlling
behavioral disturbances in dementia patients. In 1999, Abbott was forced
to discontinue a clinical trial of Depakote in the treatment of dementia
due to an increased incidence of adverse events, including somnolence,
dehydration and anorexia experienced by the elderly study participants
administered Depakote.
Abbott trained its sales force to promote Depakote to health care
providers and employees of nursing homes as advantageous over
antipsychotic drugs for controlling agitation and aggression in elderly
dementia patients because Depakote was not subject to certain provisions
of the Omnibus Budget Reconciliation Act of 1987 (OBRA) and its
implementing regulations designed to prevent the use of unnecessary
medications in nursing homes. Exploiting the fact that certain OBRA
provisions did not yet apply to Depakote, Abbott sales representatives
stated that by using Depakote, nursing homes could avoid the
administrative burdens and costs of complying with OBRA.
Abbott's off-label promotion of Depakote was multifaceted. The company
entered into contracts that provided long-term care pharmacy providers
with payments of rebates based on increases in the use of Depakote in
nursing homes serviced by the providers. In addition to using its sales
force to promote the drug to health care providers and employees of
nursing homes, Abbott created programs and materials to train the
pharmacy providers' consultant pharmacists about the off-label use of
Depakote to encourage them to recommend the drug for this unapproved
use. Under these contracts, Abbott paid millions of dollars in rebates
to the pharmacy providers.
"Not only did Abbott engage in off-label promotion, but it targeted
elderly dementia patients and downplayed the risks apparent from its own
clinical studies," said Acting Associate Attorney General Tony West. "As
this criminal and civil resolution demonstrates, those who put profits
ahead of patients will pay a hefty price."
Illegal Off-Label Promotion of Depakote for Schizophrenia
In the agreed statement of facts, Abbott also admitted that from 2001
through 2006, the Company misbranded Depakote by marketing the drug to
treat schizophrenia. Abbott funded two studies of the use of Depakote to
treat schizophrenia, and both failed to meet the main goals established
for the study. When the second study failed to show a statistically
significant treatment difference between antipsychotic drugs used in
combination with Depakote and antipsychotic drugs alone, Abbott waited
nearly two years to notify its own sales force about the study results
and another two years to publish those results. During this time, Abbott
continued to promote Depakote off-label to treat schizophrenia.
"Today's settlement demonstrates our continued scrutiny of the sales and
marketing practices of pharmaceutical companies that put profits ahead
of patient health," said U.S. Food and Drug Administration Commissioner
Margaret Hamburg, M.D. "The FDA will continue its due diligence and hold
pharmaceutical companies accountable for marketing practices that
undermine the drug approval process."
Criminal Plea
Today's global resolution has criminal, civil and administrative
components. First, Abbott has pleaded guilty to a criminal misdemeanor
for misbranding Depakote in violation of the FDCA. Under the plea
agreement, Abbott will pay a criminal fine of $500 million, forfeit
assets of $198.5 million, and submit to a term of probation for five
years. In addition, Abbott will also pay $1.5 million to the Virginia
Medicaid Fraud Control Unit. As a condition of probation, Abbott will
report any probable FDCA violations to the probation office, its CEO
will certify compliance with this reporting requirement, and its board
will report annually on the effectiveness of the company's compliance
program. In addition, Abbott agrees that during the term of probation,
the company will not compensate sales representatives for off-label
sales, will ensure that continuing medical education grant-making
decisions are not controlled by sales and marketing, will require that
letters communicating medical information to healthcare providers be
accurate and unbiased, and will have policies designed to ensure that
clinical trials are approved by the company's medical or scientific
organizations and published in a consistent and transparent manner.
Abbott's guilty plea and sentence are not final until accepted by the
U.S. District Court for the Western District of Virginia.
"As the agreed statement of facts filed in court today demonstrates,
Abbott promoted Depakote to control behaviors in elderly dementia and
schizophrenia patients without significant evidence of its effectiveness
for that use, and even after clinical data established that it was not
effective," said Timothy Heaphy, U.S. Attorney for the Western District
of Virginia. "The resolution announced today includes a self-policing
mechanism by which Abbott's board of directors will monitor compliance
with the law and report any violations, as well as a period of probation
and court supervision. We credit Abbott's acceptance of responsibility
and encourage other pharmaceutical companies to impose the similar
mechanisms to prevent off-label marketing, which damages health care
consumers."
Civil Settlement
Under the civil settlement, Abbott has agreed to pay $800 million to the
federal government ($560,851,357) and the states ($239,148,643) that opt
to participate in the agreement to resolve claims that its unlawful
marketing and illegal remuneration practices caused false claims to be
submitted to government health care programs such as Medicare, Medicaid,
TRICARE and to the Federal Employees Health Benefit Program, the
Department of Veterans' Affairs and the Department of Labor's Office of
Workers' Compensation Programs.
The civil settlement addresses broader allegations by the United States
that from 1998 through 2008, Abbott unlawfully promoted Depakote for
unapproved uses, including behavioral disturbances in dementia patients,
psychiatric conditions in children and adolescents, schizophrenia,
depression, anxiety, conduct disorders, obsessive-compulsive disorder,
post-traumatic stress disorder, alcohol and drug withdrawal, attention
deficit disorder and autism. Some of these unapproved uses were not
medically accepted indications for which the United States and state
Medicaid programs provided coverage for Depakote. The United States
contends that this promotion included, in part, making false and
misleading statements about the safety, efficacy, dosing and
cost-effectiveness of Depakote for some of these unapproved uses, and
claiming use of Depakote to control behavioral disturbances in dementia
patients would help nursing homes avoid the administrative burdens and
costs of complying with OBRA regulatory restrictions applicable to
antipsychotics.
The civil settlement also covers allegations that Abbott offered and
paid illegal remuneration to health care professionals and long term
care pharmacy providers to induce them to promote and/or prescribe
Depakote and to improperly and unduly influence the content of company
sponsored Continuing Medical Education programs, in violation of the
Federal Anti-Kickback Statute. The claims settled by the civil agreement
are allegations only and there has been no determination of liability,
except to the extent that Abbott has admitted facts in the civil
settlement agreement or in the criminal plea and agreed statement of
facts filed in the criminal action.
The civil settlement resolves four lawsuits pending in federal court in
the Western District of Virginia 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. As part of today's resolution, the whistleblowers will receive
$84 million from the federal share of the settlement amount.
Corporate Integrity Agreement
In addition to the criminal and civil resolutions, Abbott has also
executed a Corporate Integrity Agreement (CIA) with the Department of
Health and Human Services, Office of Inspector General (HHS-OIG). The
five-year CIA requires, among other things, that Abbott's board of
directors review the effectiveness of the company's compliance program,
that high-level executives certify to compliance, that Abbott maintain
standardized risk assessment and mitigation processes, and that the
company post on its website information about payments to doctors.
Abbott is subject to exclusion from federal health care programs,
including Medicare and Medicaid, for a material breach of the CIA and
subject to monetary penalties for less significant breaches.
"As a result of OIG's joint investigation with our federal and state
partners, Abbott Laboratories will enter one of the pharmaceutical
industry's largest settlements and pay $1.5 billion for unlawfully
promoting its drug Depakote, including to nursing home patients with
dementia," said HHS Inspector General Daniel R. Levinson. "Our integrity
agreement will hold Abbott accountable for preventing future violations
of federal health care laws and FDA requirements, which will protect
federal programs, taxpayers and our most vulnerable patients."
A Multilateral Effort
The criminal case is being prosecuted by the U.S. Attorney's Office for
the Western District of Virginia and the Civil Division's Consumer
Protection Branch. The civil settlement was reached by the U.S.
Attorney's Office for the Western District of Virginia and the Civil
Division's Commercial Litigation Branch. Assistance was provided by
representatives of the HHS Office of Counsel to the Inspector General;
the Center for Medicare and Medicaid Services (CMS) and Office of the
General Counsel, CMS Division; FDA's Office of Chief Counsel; and the
National Association of Medicaid Fraud Control Units.
"Crimes involving the misbranding of drugs for financial gain will not
be tolerated," stated Richard Weber, Chief IRS Criminal Investigation.
"The special agents of IRS Criminal Investigation will use all their
investigative tools, including the use of asset forfeiture statutes, to
combat financial crimes and hold corporations accountable for their
actions."
This matter was investigated by the Virginia Attorney General's Medicaid
Fraud Control Unit; the Internal Revenue Service - Criminal
Investigation; the FDA - Office of Criminal Investigation; the Defense
Criminal Investigative Service; the Health and Human Services - Office
of Inspector General; the West Virginia State Police; the Office of
Personnel Management - Office of Inspector General; the Department of
Veterans' Affairs Office of Inspector General; the Department of Labor -
Office of Inspector General; and TRICARE Program Integrity.
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. One of the most powerful tools in that effort is
the False Claims Act, which the Justice Department has used to recover
more than $7.4 billion since January 2009 in cases involving fraud
against federal health care programs. With the settlement announced
today, the Justice Department's total recoveries in False Claims Act
cases since January 2009 will exceed $10.2 billion. During this same
time, the department has secured $3.9 billion in criminal fines,
forfeiture, disgorgement, and restitution relating to violations of the
FDCA.
--
So many immigrant groups have swept through our town
that Brooklyn, like Atlantis, reaches mythological
proportions in the mind of the world - RI Safir 1998
http://www.mrbrklyn.com
DRM is THEFT - We are the STAKEHOLDERS - RI Safir 2002
http://www.nylxs.com - Leadership Development in Free Software
http://www2.mrbrklyn.com/resources - Unpublished Archive
http://www.coinhangout.com - coins!
http://www.brooklyn-living.com
Being so tracked is for FARM ANIMALS and and extermination camps,
but incompatible with living as a free human being. -RI Safir 2013
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