Illinois Suspends Medical License of Leading Prescriber of Antipsychotic Drugs
August 12th 2014
Charles Ornstein
Propublica

Illinois medical regulators have indefinitely suspended the medical licenseof
psychiatrist Michael Reinstein, who prescribed more of the most powerful and riskiest
antipsychotic drug clozapine than any other doctor in the country.

The decision by Illinois' Department of Financial and Professional Regulation, signed
Friday, suspends Reinstein's license for a minimum of three years, at which time he
can apply to have it reinstated.

The state's medical disciplinary board recommended the sanction in May after
determining that Reinstein, 71, received "illegal direct and indirect remuneration" from
the maker of generic clozapine; did not consider alternative treatments for his patients;
and disregarded patients' well-being because of potentially life-threatening side effects
of the drug. Reinstein's motion for a rehearing was denied Friday, making the matter
public.

Clozapine is approved to treat patients who don't respond to other medications. But it
can have dangerous side effects, including seizures, inflammation of the heart muscle,
and a drop in white blood cells. The drug is considered particularly dangerous for
elderly patients.

Reinstein's prescribing patterns have been explored in two ProPublica reports.

In 2009, ProPublica and the Chicago Tribune detailed how he had prescribed more of
the antipsychotic clozapine to patients in Medicaid's Illinois program in 2007 than all
doctors in the Medicaid programs of Texas, Florida and North Carolina combined.
Autopsy and court records showed that, by 2009, at least three patients under
Reinstein's care had died of clozapine intoxication. At that time, Reinstein defended his
prescription record, arguing that clozapine is effective and underprescribed.

Last year, as part of an investigation into Medicare's failure to monitor problem
prescribers, ProPublica reported that Reinstein prescribed even more clozapine in
Medicare's prescription drug program for seniors and the disabled. We found that the
program continued to let him prescribe even after the U.S. Department of Justice
accused him of fraud and Illinois' Medicaid program suspended payments to him.

Reinstein's attorney did not return a phone call or email seeking comment. An
outgoing message on Reinstein's cell phone said, "Due to a personal emergency I will
not be working as of today. I will return to work as quickly as I can."

In their response to the medical board's accusations, Reinstein's lawyers invoked his
right against self-incrimination.

The state of Illinois has the authority to permanently revoke a doctor's license, but
typically only does so for sex crimes or assaults on patients, a spokeswoman said by
email. When a doctor's license is indefinitely suspended, as is the case with Reinstein,
the doctor must apply after a set time to return to practice; the state's approval is not
automatic.

The federal fraud lawsuit against Reinstein is pending in U.S. District Court in Chicago.
In a November 2012 news release announcing the case, the government said that
Reinstein "received illegal kickbacks from pharmaceutical companies and submitted at
least 140,000 false claims to Medicare and Medicaid for antipsychotic medications he
prescribed for thousands of mentally ill patients in area nursing homes."

Prosecutors allege that Reinstein's prescribing decisions were motivated by money
and perks from pharmaceutical companies. He allegedly switched patients from one
brand of clozapine to another based on money and other enticements he received
from a drugmaker.

In March, Teva Pharmaceutical Industries Ltd., the maker of generic clozapine, agreed
to pay more than $27.6 million to settle state and federal allegations that it induced
Reinstein to prescribe the drug.

Reinstein's prescribing of clozapine appears to have declined after the 2009 articles
about him. From 2007 to 2009, he wrote an average of 20,000 Medicare prescriptions
annually for clozapine and a brand-name version, FazaClo. That figure dropped to
about 8,000 in 2012, according to data obtained by ProPublica.

Check out how your doctor's prescribing within Medicare compares to others in his or
her specialty in your state. Visit ourPrescriber Checkup tool.
Blog posts--Thank heaven for insurance
companies


Wednesday, April 23, 2014
UCLA pays $10 million for retaliation against surgeon who
exposed industry payments that may have compromised
patient care
This case is just a small part of a larger problem at UCLA. Another small part of
the problem, the behavior of Eugene Washington, dean of the David Geffen
Medical School at UCLA, is discussed HERE.

UCLA'S $10 MILLION WHISTLE-BLOWER RETALIATION CASE:

  "Shortly before Pedowitz joined UCLA in 2009, the university was already facing
criticism from Congress over the failure of a top spine surgeon to report nearly
$460,000 in payments he received from Medtronic and other medical companies
while researching their products' use in patients, government records show.

  "Dr. Jeffrey Wang, who left for USC Spine Center last fall, stepped down as head
of UCLA's spine program in 2009 after U.S. Sen. Charles Grassley (R-Iowa)
publicized his lapse in disclosure as part of a larger investigation into medical
conflicts of interest.

  "Several patients are now suing Wang and UCLA in state court for negligence,
fraud and malpractice in connection with surgeries involving Medtronic's
controversial Infuse bone graft."

  "...'What good are all the policies if they protect the wrongdoers and fail to
protect the actual whistleblower?' Quigley said. 'The university wanted to cover it
all up.'"




UCLA surgeon Dr. Robert Pedowitz, who said the medical school allowed doctors
to take industry payments that may have compromised patient care

UC OKs paying surgeon $10 million in whistleblower-retaliation case
The settlement ends a case brought by the ex-head of UCLA's orthopedic surgery
department
By Chad Terhune
Los Angeles Times
April 22, 2014

University of California regents agreed to pay $10 million to the former chairman
of UCLA's orthopedic surgery department, who had alleged that the well-known
medical school allowed doctors to take industry payments that may have
compromised patient care.

The settlement reached Tuesday in Los Angeles County Superior Court came just
before closing arguments were due to begin in a whistleblower-retaliation case
brought by Dr. Robert Pedowitz, 54, a surgeon who was recruited to UCLA in 2009
to run the orthopedic surgery department.

In 2012, the surgeon sued UCLA, the UC regents, fellow surgeons and senior
university officials, alleging they failed to act on his complaints about widespread
conflicts of interest and later retaliated against him for speaking up.

UCLA denied Pedowitz's allegations, and officials said they found no wrongdoing
by faculty and no evidence that patient care was jeopardized. But the UC system
paid him anyway, saying it wanted to avoid the "substantial expense and
inconvenience" of further litigation.

[Maura Larkins: Closing arguments were about to begin in the case. UCLA had
already invested "substantial expense and inconvenience", and would have
incurred very little expense or inconvenience if it had simply allowed the closing
arguments to go forward. The reason it settled was that it realized that the weight
of the evidence showed that UCLA did indeed jeopardize patient safety and
certainly violated conflict of interest standards and the legal rights of the whistle-
blower.]

As department chairman, Pedowitz testified, he became concerned about
colleagues who had financial ties to medical-device makers or other companies
that could unduly influence their care of patients or taint important medical
research.

He also alleged that UCLA looked the other way because the university stood to
benefit financially from the success of medical products or drugs developed by its
doctors.

One of the orthopedic surgeons that Pedowitz complained about testified at trial
about receiving $250,000 in consulting fees in 2008 from device maker Medtronic.
In memos to university officials, Pedowitz raised concerns about the financial
dealings of other doctors as well.

Inside the courtroom Tuesday, Pedowitz sat in the front row with his wife and
daughter as the judge told jurors that a settlement had been reached. He said he
felt vindicated by the outcome.

"These are serious issues that patients should be worried about," Pedowitz said in
an interview. "These problems exist in the broader medical system and they are
not restricted to UCLA."

The seven-week trial in downtown Los Angeles offered a rare glimpse into those
potential conflicts at a time when there is growing government scrutiny of industry
payments to doctors.

Starting this fall, the federal Physician Payments Sunshine Act, part of President
Obama's healthcare law, requires public disclosure of financial relationships
between healthcare companies and physicians.

Many doctors and universities defend long-standing industry arrangements as
essential for carrying out cutting-edge research and top-flight medical education.

In a statement Tuesday, the UC regents said they "resolved this lawsuit to end a
prolonged conflict and permit UCLA Health Sciences to refocus on its primary
missions of teaching, research, patient care and community engagement."

The statement added that "multiple investigations by university officials and
independent investigators concluded that conduct by faculty members was lawful.
Patient care was not compromised."

This latest settlement eclipses a $4.5-million payout the UC regents made last
year to resolve a racial discrimination lawsuit filed by another UCLA surgeon.

Pedowitz, as part of his settlement, left the UCLA faculty, effective Tuesday. He
had agreed to step down as department chairman in 2010 after initially voicing his
concerns to top UCLA officials. He filed a whistleblower retaliation complaint in
March 2011.

Experts in medical ethics say the UCLA case shows much more needs to be done
within academia and by government regulators to address potential conflicts of
interest in medicine.

Susan Chimonas, associate director of research at Columbia University's Center
on Medicine as a Profession, said some medical schools are still reluctant to take
on specialists who bring in considerable money from patients, medical research
and patents on breakthrough products.

"Institutions can be dependent on the money these big-earning specialties like
orthopedic surgery bring in," Chimonas said. "They are the cash cows and they
can set their terms. This is not the first time I've heard of medical schools having
policies that are not well enforced."

In an interview last week, the chief compliance officer at the UCLA Health System
flatly rejected the notion that the university didn't enforce its policies or look fully
into Pedowitz's allegations. She also said industry ties are unavoidable at a big
medical school and rules are in place to prevent conflicts.

"We have processes in place to identify those relationships in a transparent
fashion and ensure they don't have any inappropriate influence on the actions of
the university," said Marti Arvin, chief compliance officer. "In order to meet our
mission, it is important we have both the brilliant minds we have at UCLA and
collaboration with industry."

Arvin said the university "thoroughly and objectively investigated those allegations
of noncompliance raised by Dr. Pedowitz. We were able to determine the vast
majority were unsubstantiated."

She said two doctors fell short of university expectations in their handling of
outside income, but there was no violation of law or university policy in either
instance.

Arvin cited the case of Dr. Nick Shamie, the orthopedic surgeon who testified at
trial about receiving $250,000 from Medtronic for consulting work. She said
department policy at the time didn't require Shamie to send that outside income
through UCLA's faculty compensation plan.

At trial, Pedowitz said he was deeply troubled by the large amount of money
Shamie was paid. He testified that he was particularly concerned that Shamie was
trying to enroll patients in a research study involving Medtronic at the time.

"I saw this as an obvious problem," Pedowitz testified.

In court, Shamie said he abided by university policy and didn't pursue the study
further because finding patients was too difficult. He couldn't be reached for
additional comment.

The other physician cited by Arvin for a potential shortcoming was Dr. David
McAllister, vice chairman of clinical operations for the orthopedic surgery
department.

He didn't report payments from the Musculoskeletal Transplant Foundation, a
nonprofit tissue bank that does business with UCLA, because he didn't think
disclosure was required in that instance because it didn't involve a for-profit entity,
Arvin said.

McAllister also declined to comment, referring a call to UCLA.

Shortly before Pedowitz joined UCLA in 2009, the university was already facing
criticism from Congress over the failure of a top spine surgeon to report nearly
$460,000 in payments he received from Medtronic and other medical companies
while researching their products' use in patients, government records show.

Dr. Jeffrey Wang, who left for USC Spine Center last fall, stepped down as head of
UCLA's spine program in 2009 after U.S. Sen. Charles Grassley (R-Iowa)
publicized his lapse in disclosure as part of a larger investigation into medical
conflicts of interest.

Several patients are now suing Wang and UCLA in state court for negligence,
fraud and malpractice in connection with surgeries involving Medtronic's
controversial Infuse bone graft. UCLA said it doesn't comment on pending
litigation. Wang couldn't be reached for comment.

Shortly after raising his concerns, Pedowitz said, he was pressured to step down
as department chairman in 2010. Pedowitz said he was further retaliated against
by being denied patient referrals and prevented from participating in grants and
other activities.

Before UCLA, Pedowitz worked at UC San Diego and as chairman of orthopedics
and sports medicine at the University of South Florida.

Mark Quigley, an attorney representing Pedowitz, said the case could have been
avoided if the UC system enforced the policies it already has in place.

"What good are all the policies if they protect the wrongdoers and fail to protect
the actual whistleblower?" Quigley said. "The university wanted to cover it all up."


Posted by Maura Larkins at 9:50 AM No comments: Links to this post
Labels: cover-up, doctor ethics, ethics, kickbacks, medical devices, orthopedic surgeon,
secrecy in hospitals, UCLA, UCLA lawsuits, UCLA Medical Center, UCLA secrecy, whistle-
blower, white coat crime




Sunday, January 12, 2014
Novartis Accused of Paying Kickbacks to
Boost Exjade Sales
By Christie Smythe
Bloomberg Business Week
January 08, 2014

A Novartis AG (NOVN) unit was accused by the U.S. and a group of states of
paying kickbacks to a specialty pharmacy to boost sales of Exjade, an iron-control
drug that can cause kidney and liver failure.

U.S. District Judge Colleen McMahon in Manhattan today unsealed a complaint
filed against Novartis Pharmaceuticals Corp. by the U.S., 26 states and the District
of Columbia alleging that the drugmaker had paid kickbacks to BioScrip Inc. (BIOS:
US) to encourage patients to refill prescriptions.

Separately, federal and state officials announced that the Elmsford, New York-
based specialty pharmacy agreed to pay $15 million to resolve the claims against
it.

Federal and state officials alleged that government health programs Medicare and
Medicaid paid tens of millions of dollars in reimbursements based on false claims
for the drug.

“This arrangement between Novartis and BioScrip was dangerous for patients and
is against the law,” New York Attorney General Eric Schneiderman said in a
statement. “Our lawsuit against Novartis and our agreement with BioScrip send a
clear message: Drug companies cannot pay pharmacies to promote drugs directly
to patients.”

Kickbacks, Calls

According to the complaint, Novartis paid kickbacks to BioScrip from February
2007 to May 2012 in the form of patient referrals and rebates. To hold up its end
of the bargain, BioScrip made tens of thousands of calls to patients to try to
convince them to keep taking the drug, federal and state officials alleged.

Julie Masow, a spokeswoman for Basel, Switzerland-based Novartis, said in an e-
mailed statement that the company disputes the allegations in the complaint
related to its interactions with BioScrip and intends to defend itself.

The company “is dedicated to improving patient health and supports patient
medication adherence programs,” including outreach by pharmacies, Masow said.

Exjade was approved by the U.S. Food and Drug Administration in November
2005 to treat chronic iron overload due to blood transfusions, according to the
complaint. In January 2010, the agency required the drug to feature a “black box”
warning highlighting the potential for kidney failure, liver failure and
gastrointestinal hemorrhage that in some cases were fatal, according to the
complaint.

Increasing Refills

Novartis wanted to increase the refills of the drug because “its own market
research had shown that a significant percentage of physicians and patients were
opting to discontinue Exjade therapy” because of side effects, the officials said in
the complaint.

In late February 2007, Novartis told BioScrip that because it generated lower
levels of refills compared with other pharmacies, it had been placed on a
“performance improvement plan,” according to the complaint.

Novartis “expects that the specialty pharmacies it works with conduct vital patient
outreach in a manner wholly consistent with NPC’s commitment to patient care,”
Masow said. “BioScrip reached out to patients using its own protocols to provide
education, counseling and information about proper administration of the medicine
and to fulfill prescriptions that have been prescribed by a patient’s treating
physician.”

Officials are seeking triple damages against Novartis and civil penalties under the
False Claims Act.

The case is ABC v. DEF, 1:11-cv-08196, U.S. District Court, Southern District of
New York (Manhattan).

Posted by Maura Larkins at 8:23 PM No comments: Links to this post
Labels: doctors bought by drug companies, drug companies, drug company
representatives, drugs, kickbacks, lawsuits, Novartis, pharmaceutical companies



Wednesday, July 4, 2012
Dr. Drew Pinsky responds to allegations he
received GlaxoSmithKline payments
By Michelle Castillo
July 4, 2012
(CBS News)

After being accused of taking payments from GlaxoSmithKline to promote the
antidepressant Wellbutrin, Dr. Drew Pinksy told CBS News everything he said was
in accordance with the law and accurate according to his medical experience.

"In the late 90s I was hired to participate in a 2-year initiative discussing intimacy
and depression which was funded by an educational grant by Glaxo Wellcome,"
Pinksy told HealthPop in a statement. "Services for the non-branded campaign
included town hall meetings, writings and multimedia activities in conjunction with
the patient advocacy group the National Depresive and Manic Depressive
Association (NDMDA). My comments were consistent with my clinical experience."

Pinsky - a board-certified internist, addiction medicine specialist, and radio and
television personality - was mentioned in a complaint filed by the U.S. government
against the pharmaceutical company, according to the Forbes.

The document states that Pinksy allegedly received two payments in March 2009
and April 2009 from GlaxoSmithKline totaling $275,000 to promote Wellbutrin SR.
The Wall Street Journal reported in June 1999, he made statements on "Loveline,"
a television and radio show he co-hosted, saying that he prescribed Wellbutrin to
depressed patients because it "may enhance or at least not suppress sexual
arousal" as much as other antidepressants are known to do. Pinsky was also
reported to have made comments on other media, including another national radio
program called "David Essel - Alive!," Forbes added. In both instances, he did not
disclose that he was paid by the company to do so, and he promote uses of
Wellbutrin that had not been approved by the Food and Drug Administration.

GlaxoSmithKline recently plead guilty and had to pay $3 billion in the largest
settlement of health care fraud in U.S. history, HealthPop reported. The company
was charged with unlawful promotion of certain prescription drugs.
Posted by Maura Larkins at 2:39 PM No comments: Links to this post
Labels: doctor ethics, doctors bought by drug companies, drug companies, fraud,
GlaxoSmithKline, healthcare fraud, kickbacks, Wellbutrin
California doctors sue Aetna for coverage denials
Is it possible that both the doctors and the insurance companies are ripping off
patients? Doctors are apparently getting kickbacks for referring patients.

California doctors sue Aetna for coverage denials
Jul 3, 2012
By Toni Clarke
(Reuters)

Thousands of doctors in California are suing the health insurance company Aetna
Inc claiming the company routinely denies patients access to out-of-network
doctors even when the patient has purchased a policy giving them the right to
choose providers.

The lawsuit, filed in the Los Angeles County Superior Court, accuses Aetna of
threatening patients with denial of coverage if their members visit doctors outside
the Aetna network of providers, and of threatening doctors with having their Aetna
contracts terminated if they refer patients outside the network.

The lawsuit was brought by the Los Angeles County Medical Association,
California Medical Association and a coalition of health care organizations and
providers.

Aetna claims the suit is in retaliation for a suit filed by Aetna in February claiming
several California providers, including Bay Area Surgical Management (BASM)and
seven ancillary facilities, sent Aetna members to BASM without revealing that
physicians had an ownership interest in the facility or were getting paid by BASM
for their referrals.

"We have sued some of these same doctors and surgery centers named in the
suit for their egregious billing practices in February of this year," Cynthia
Michener, a spokeswoman for Aetna, said in an email. "This is a countersuit
disguised as a class action lawsuit."

Michener said Aetna would "continue to pursue medical providers whose charges
are so grossly out of line."

She cited as examples facilities and doctors who have charged $73,536 for a
kidney stone fragmentation when an average in-network charge would be around
$7,612. Or those that have charged $37,572 for a knee procedure that would cost
about $10,500 with an in-network physician.

Michener was not immediately able to say what the average cost of these
procedures would have been in out-of-network facilities that are not being sued by
Aetna.

The lawsuit brought by the physicians accuses Aetna of false advertising, breach
of contract, unfair business practices, and both intentional and negligent
interference with healthcare providers.

The lawsuit seeks an end to the practices, an immediate injunction, compensation
for patients and physicians and punitive damages.

"Despite making tens of millions of dollars selling policies with out-of-network
benefits, Aetna has engaged in a campaign to retaliate against its members who
attempt to use their out-of-network benefits, and the physicians who refer these
members to out-of-network providers," the lawsuit states.
Posted by Maura Larkins at 9:38 AM No comments: Links to this post
Labels: Aetna, denial by insurance company, insurance profits, kickbacks, lawsuits


Wednesday, March 7, 2012
U-T: Scripps Mercy Cited In State Probe; 4
Fired
Investigators Say Workers Took Gifts, Steered Patients Into Certain Nursing
Homes
Janet Lavelle, U-T San Diego
March 7, 2012

SAN DIEGO -- Scripps Mercy Hospital has fired four case managers and
overhauled operations after state investigators found the employees broke state
and federal laws by taking gifts from a nursing home owner and by steering
patients into certain homes instead of giving them a choice when they left the
hospital.

The California Department of Public Health launched an investigation in mid-
November and two state Department of Justice investigators also participated.

Health department officials issued a deficiency report detailing the violations and
last week approved a Plan of Correction that Scripps Mercy filed in response.
The state Department of Justice has filed no charges and “there is nothing we’re
actively doing with this,” said Lynda Gledhill, press secretary for state Attorney
General Kamala Harris.
Officials at the five-hospital Scripps Health system released a lengthy statement
Tuesday, which said in part, “Scripps does not condone this type of behavior by
employees. We work to ensure patients have a voice in their care. We regret this
happened and have taken steps to prevent it from happening again.”
Those steps included demoting one supervisor and reorganizing the case
management leadership, tightening auditing and conflict-of-interest procedures,
and holding employee training classes.
Scripps spokeswoman Janice Collins said, “We started implementing a lot of the
changes in January.”
Scripps Mercy, which employs 15 case managers, started its own investigation in
October after getting a complaint from a patient who hadn’t been given a choice in
nursing homes, Collins said.
State law requires hospitals to give a patient being transferred to a skilled nursing
facility a list of options, without offering a recommendation, and then honor the
patient’s choice.
In November, state and hospital investigators looked at medical records for 108
patients referred to nursing homes between May and October 2011. Interviews
with patients and their families were compared with medical records and
discrepancies were found involving five case managers who gave patients few or
no choices among nursing facilities but documented that they had.
The five case managers told investigators they had gotten a free dinner boat
cruise from one nursing home owner, and one case manager, who also received a
$50 gift card, said “an established relationship” with that operator influenced her,
according to the state report. One case manager also failed to disclose that her
son worked at the nursing home, a violation of state conflict-of-interest laws.
The report didn’t name any nursing home facilities or operators. State Department
of Public Health officials could not say Tuesday whether any nursing home has
been cited as part of the investigation, department spokesman Ralph Montano
said.
San Diego Education Report
SDER
San Diego
Education Report
SDER
SDER
SDER
News, information and ideas about our
education system, courts and health care
by Maura Larkins
YOU MUST FILE A
TORT CLAIM AT A
SPECIFIC UC CAMPUS
HEALTH CENTER
RATHER THAN THE
STATE OF CALIFORNIA

The University of
California works hard to
conceal the tort claim
process.  You can't sue if
you don't file a tort claim
within 6 months.

At first I was duped by a
document published by the
Regents of the
University of California.  































In fact, "section 1 above",
does not inform the
reader that he must serve
a tort claim on the UC
campus involved.  
Instead, it provides an
address in San Francisco.  
It's the wrong address for
filing a tort claim.  Clearly,
the Regents want patients
to come to them for health
care, but if they harm the
patient, they don't want
him to be able to file a
claim.
[Warning--the following
statement from the
Office of The General
Counsel of the UC
Regents (“OGC”) is
deceptive; read more
below.]

"THE REGENTS IS NOT
SUBJECT TO CLAIM-
FILING PROVISIONS OF
THE TORT CLAIMS ACT
"California Government
Code section 905.6
exempts The Regents of
the University of
California from claim-
filing provisions of the
Tort Claims Act.  A
claimant who wishes to
file suit against The
Regents may serve OGC
as specified in section 1
above."
--General Counsel of the
UC Regents ("OGC")
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