Thursday, December 17, 2009

Feds Investigating High Prescribing Florida Docs

 

http://hosted.ap.org/dynamic/stories/U/US_MEDICAID_TOP_PRESCRIBERS_FLOL-?SITE=FLPET&SECTION=HOME

 

Associated Press

Feds investigating high prescribing Fla. docs


MIAMI (AP) -- The federal government has stopped reimbursing a Miami doctor who wrote nearly 97,000 prescriptions for mental health drugs to Medicaid patients over 18 months, in a case that prompted a key Senator to call for a nationwide investigation.

U.S. Sen. Sen. Charles Grassley of Iowa said Dr. Fernando Mendez Villamil wrote an average of 153 prescriptions a day for 18 months ending in March 2009. That's nearly twice the number of the second highest prescriber in Florida, who wrote a little more than 53,000 prescriptions, according to a list compiled by state officials.

Grassley, an Iowa Republican and ranking member of the Senate Finance Committee, which oversees Medicare and Medicaid, called the figures alarming and sent a letter Wednesday to the Department of Health and Human Services asking the agency to investigate top prescribers across the country. His inquiry comes as the government targets waste and fraud in the taxpayer funded programs.

HHS officials said they were aware of Florida's list of high prescribing doctors and were working closely with the state and federal agencies that investigate Medicaid fraud, according to a statement from Sec. Kathleen Sebelius' office.

Dr. Villamil hasn't been reimbursed by Medicare since May when HHS started investigating him.

An employee at Villamil's office declined to comment and a voicemail left at his office Thursday was not immediately returned.

"It's hard to believe that this dramatic level of activity could go unnoticed," Grassley told The Associated Press.

"It's a matter of program integrity, taxpayer protection and patient safety," added Grassley, who asked HHS officials to explain whether and how the agency tracks high-prescribing doctors.

The vast majority of the doctors near the top of Florida's list are in the Miami area, where Medicare fraud totals over $3 billion a year, higher than any place else in the country.

"The highest prescribers are always in Miami," said Karen Koch, vice president of the Florida Council for Community Mental Health. "They tend to use medication more maybe than in some others areas and then sometimes it's an anomaly in the data."

Koch said that some doctors on the list have multiple practices with other prescribers using their license, which is legal. The state also has a shortage of psychiatrists, meaning a smaller number of doctors are serving more patients each.

And sometimes patients doctor shop with the intention of selling the drugs, which also drives up prescription numbers.

The drugs that Villamil, a psychiatrist, prescribed most commonly included Seroquel, Zyprexia and Abilify.

Seroquel is the only drug that has street value in the United States. "When snorted, it acts like cocaine," said Koch. The other drugs "have high street value in South American countries because it is not available there so families in the U.S. are always trying to get it for their relatives there," she said.

The state's top prescriber list is part of the Medicaid Drug Therapy Management Program, which began monitoring mental and behavioral health medications when the program was created in 2006.

"The number of prescriptions recorded for Dr. Fernando Mendez-Villamil is high when compared to other Medicaid prescribers," state Agency for Health Care Administration spokesman Sue Conte said in an e-mail to The Associated Press.

However, she said "it does not indicate that there is anything improper regarding his prescribing," saying patients seeing a specialist like Villamil would need daily medications plus medications for acute episodes. Villamil's prescriptions also included refills, she said.

If a concern arises, AHCA's Office of Inspector General will more thoroughly investigate billing practices and prescribing patterns. If fraud is suspected, the case is sent to the Florida's Attorney General. About 123 cases were referred to the Medicaid Fraud unit in the past fiscal year, according to AHCA.

A spokesman for Florida's Attorney General said the office has a pending investigation into Villamil, stemming from a 2007 request from a private citizen. She declined to comment further.

A Florida doctor who prescribed several mental health medications to a 7-year-old foster care boy who killed himself in April is also on the list. The drugs carried a special FDA black box warning indicating they can cause suicidal thoughts and are not approved for young children, though some doctors still prescribe them to treat children.

Dr. Sohail Punjwani wrote 10,150 prescriptions during the same two year period, according to the report.

Dr. Punjwani, who has appeared on the high-prescriber list multiple times but has never been sanctioned, did not immediately return a phone call left by The Associated Press on Thursday.

Grassley's letter comes months after Gabriel Myers hung himself with a shower cord at his foster parents' home while under Punjwani's care. The boy's death prompted debate at the state's child welfare agency about stricter rules for prescribing powerful antidepressants and other drugs to foster children.

 

Senator Grassley Eyes Miami Psychiatrist

http://www.miamiherald.com/business/story/1385651.html

 

 U.S. Sen. Grassley

 

Miami Herald

Senator eyes Miami doctor

Sen. Charles Grassley pointed to a Miami doctor in an attempt to show that the government needs to do something about over-utilization of healthcare.

By John Dorschner

A Miami psychiatrist who writes prescriptions for Medicaid patients at a rate of 150 a day, seven days a week, has been targeted by a U.S. senator as an example of why the federal government should do more to investigate over-utilization of healthcare.

The biting letter, from Sen. Charles Grassley, R-Iowa, to federal Medicaid officials comes at a time when authorities are looking for ways to reduce what experts believe is massive overspending in areas like Miami, where healthcare costs can be more than twice the national average, as healthcare reform advocates look for ways to find the money to spread coverage to the uninsured.

The Grassley letter does not mention Fernando Mendez-Villamil by name, but noted ``with alarm'' documents from the Florida Agency for Healthcare Administration about a single prescriber who wrote 96,685 prescriptions from the last half of 2007 through the first quarter of 2009 for Medicaid patients.

AHCA records independently obtained by The Miami Herald show that the doctor is Mendez-Villamil, who wrote nearly twice as many prescriptions for mental health drugs as the No. 2 Medicaid prescriber in the state.

The huge number ``means that this physician wrote approximately 153 prescriptions each and every day, assuming he did not take vacations,'' Grassley wrote.

Mendez-Villamil told The Herald he works long hours and sees patients only for 10 minutes every two or three months. Medicaid pays him $45 per office visit. Each patient may require four or five prescriptions, he said, accounting for the large numbers he writes.

``When you know the patient, and the patient is stable, 10 minutes is long enough,'' said Mendez-Villamil, whose office is on Coral Way. He said he sometimes works 12-hour days during the week as well as Saturday mornings. He said he only prescribes what's medically necessary.

A reporter visiting his office at 8 a.m. on Saturdays has found a couple of dozen patients milling around out front, waiting to get in to see him.

Mendez-Villamil, 42, received his medical degree from the Universidad Central del Caribe in Puerto Rico. He did his residency in psychiatry at Jackson Memorial Hospital and has been licensed in the state since 1998.

EXPENSIVE PRESCRIPTIONS

The mental health drugs that Mendez-Villamil prescribes do not generally have a value as street drugs but they are expensive. He writes thousands of prescriptions a year for Zyprexa ($841.93 for 30-day supply at Drugstore.com), Abilify ($634) and Seroquel ($430). All Medicaid drugs are paid for by Florida taxpayers.

David Katz, a Yale doctor specializing in public health issues, said it's tough to critique a doctor's work from afar, but he and others have abiding concerns about mental health treatment for underserved populations, such as poor Medicaid patients. Low reimbursement rates can lead to the ``knee-jerk use of prescription medications,'' which can ``translate into substandard care and preventable harm.''

Alfred Jonas, a Miami psychiatrist who's been practicing for more than a quarter-century, said he wondered about Mendez-Villamil's practice. ``There are psychiatric patients who can be seen every two months because they are so stable,'' Jonas said, ``but it's inconceivable to me that one's entire caseload would be like that, especially if they require four or five medications.

``And if they require that many prescriptions, it's unlikely that many wouldn't also need psychotherapy,'' which requires far more than a 10-minute session. ``It's all way too much for coincidence.''

In his letter to Kathleen Sebelius, secretary of Health and Human Services, Grassley demanded to know ``what systems'' federal agencies ``have in place to monitor utilization rates across the country?''

NOTHING IMPROPER

In an e-mail to The Herald Thursday afternoon, AHCA Press Secretary Tiffany Vause wrote that the state has a contract with the University of South Florida to monitor prescribing practices of doctors who write behavioral health prescriptions.

``The number of prescriptions recorded for Dr. Fernando Mendez-Villamil is high when compared to other Medicaid prescribers,'' Vause wrote, but the number does not ``indicate that there is anything improper regarding his prescribing. If a doctor is a specialist like Dr. Fernando Mendez-Villamil. . . it can be expected that he would have a high number of clients requiring the specialized treatment offered by psychiatric medications.''

MONITORING SYSTEM

Vause wrote many of the prescriptions the psychiatrist wrote could have been for refills. She said AHCA uses a warning system of ``edits'' that indicate causes for concern about a doctor's prescribing patterns. ``Mendez-Villamil has a small percentage of prescriptions that hit against these edits.''

Drug makers recommend that doctors monitor closely patients taking atypical antipsychotics, because users are prone to obesity and diabetes. In 2007, Mendez-Villamil prescribed this class of drugs 6,000 times, state records show. He told The Herald that he leaves possible side effects, such as diabetes, to the patients' general practitioners.

 

 

Monday, December 14, 2009

NYTimes - Poor Children Likelier to Get Antipsychotics

http://www.nytimes.com/2009/12/12/health/12medicaid.html

 

Poor Children Likelier to Get Antipsychotics

New York Times

By DUFF WILSON

Published: December 11, 2009

New federally financed drug research reveals a stark disparity: children covered by Medicaid are given powerful antipsychotic medicines at a rate four times higher than children whose parents have private insurance. And the Medicaid children are more likely to receive the drugs for less severe conditions than their middle-class counterparts, the data shows.

http://graphics8.nytimes.com/images/2009/12/12/business/12medicaid_CA0/articleInline.jpg

Suzanne DeChillo/The New York Times

Dr. Derek H. Suite, a psychiatrist in the Bronx, says he sees many children on antipsychotic drugs who do not need them.

Multimedia

Children and Antipsychotic DrugsGraphic

Children and Antipsychotic Drugs

Those findings, by a team from Rutgers and Columbia, are almost certain to add fuel to a long-running debate. Do too many children from poor families receive powerful psychiatric drugs not because they actually need them — but because it is deemed the most efficient and cost-effective way to control problems that may be handled much differently for middle-class children?

The questions go beyond the psychological impact on Medicaid children, serious as that may be. Antipsychotic drugs can also have severe physical side effects, causing drastic weight gain and metabolic changes resulting in lifelong physical problems.

On Tuesday, a pediatric advisory committee to the Food and Drug Administration met to discuss the health risks for all children who take antipsychotics. The panel will consider recommending new label warnings for the drugs, which are now used by an estimated 300,000 people under age 18 in this country, counting both Medicaid patients and those with private insurance.

Meanwhile, a group of Medicaid medical directors from 16 states, under a project they call Too Many, Too Much, Too Young, has been experimenting with ways to reduce prescriptions of antipsychotic drugs among Medicaid children.

They plan to publish a report early next year.

The Rutgers-Columbia study will also be published early next year, in the peer-reviewed journal Health Affairs. But the findings have already been posted on the Web, setting off discussion among experts who treat and study troubled young people.

Some experts say they are stunned by the disparity in prescribing patterns. But others say it reinforces previous indications, and their own experience, that children with diagnoses of mental or emotional problems in low-income families are more likely to be given drugs than receive family counseling or psychotherapy.

Part of the reason is insurance reimbursements, as Medicaid often pays much less for counseling and therapy than private insurers do. Part of it may have to do with the challenges that families in poverty may have in consistently attending counseling or therapy sessions, even when such help is available.

"It's easier for patients, and it's easier for docs," said Dr. Derek H. Suite, a psychiatrist in the Bronx whose pediatric cases include children and adolescents covered by Medicaid and who sometimes prescribes antipsychotics. "But the question is, 'What are you prescribing it for?' That's where it gets a little fuzzy."

Too often, Dr. Suite said, he sees young Medicaid patients to whom other doctors have given antipsychotics that the patients do not seem to need. Recently, for example, he met with a 15-year-old girl. She had stopped taking the antipsychotic medication that had been prescribed for her after a single examination, paid for by Medicaid, at a clinic where she received a diagnosis of bipolar disorder.

Why did she stop? Dr. Suite asked. "I can control my moods," the girl said softly.

After evaluating her, Dr. Suite decided she was right. The girl had arguments with her mother and stepfather and some insomnia. But she was a good student and certainly not bipolar, in Dr. Suite's opinion.

"Normal teenager," Dr. Suite said, nodding. "No scrips for you."

Because there can be long waits to see the psychiatrists accepting Medicaid, it is often a pediatrician or family doctor who prescribes an antipsychotic to a Medicaid patient — whether because the parent wants it or the doctor believes there are few other options.

Some experts even say Medicaid may provide better care for children than many covered by private insurance because the drugs — which can cost $400 a month — are provided free to patients, and families do not have to worry about the co-payments and other insurance restrictions.

"Maybe Medicaid kids are getting better treatment," said Dr. Gabrielle Carlson, a child psychiatrist and professor at the Stony Brook School of Medicine. "If it helps keep them in school, maybe it's not so bad."

In any case, as Congress works on health care legislation that could expand the nation's Medicaid rolls by 15 million people — a 43 percent increase — the scope of the antipsychotics problem, and the expense, could grow in coming years.

Even though the drugs are typically cheaper than long-term therapy, they are the single biggest drug expenditure for Medicaid, costing the program $7.9 billion in 2006, the most recent year for which the data is available.

The Rutgers-Columbia research, based on millions of Medicaid and private insurance claims, is the most extensive analysis of its type yet on children's antipsychotic drug use. It examined records for children in seven big states — including New York, Texas and California — selected to be representative of the nation's Medicaid population, for the years 2001 and 2004.

 

 

The data indicated that more than 4 percent of patients ages 6 to 17 in Medicaid fee-for-service programs received antipsychotic drugs, compared with less than 1 percent of privately insured children and adolescents. More recent data through 2007 indicates that the disparity has remained, said Stephen Crystal, a Rutgers professor who led the study. Experts generally agree that some characteristics of the Medicaid population may contribute to psychological problems or psychiatric disorders. They include the stresses of poverty, single-parent homes, poorer schools, lack of access to preventive care and the fact that the Medicaid rolls include many adults who are themselves mentally ill.

Multimedia

Children and Antipsychotic DrugsGraphic

Children and Antipsychotic Drugs

As a result, studies have found that children in low-income families may have a higher rate of mental health problems — perhaps two to one — compared with children in better-off families. But that still does not explain the four-to-one disparity in prescribing antipsychotics.

Professor Crystal, who is the director of the Center for Pharmacotherapy at Rutgers, says his team's data also indicates that poorer children are more likely to receive antipsychotics for less serious conditions than would typically prompt a prescription for a middle-class child.

But Professor Crystal said he did not have clear evidence to form an opinion on whether or not children on Medicaid were being overtreated.

"Medicaid kids are subject to a lot of stresses that lead to behavior issues which can be hard to distinguish from more serious psychiatric conditions," he said. "It's very hard to pin down."

And yet Dr. Mark Olfson, a psychiatry professor at Columbia and a co-author of the study, said at least one thing was clear: "A lot of these kids are not getting other mental health services."

The F.D.A. has approved antipsychotic drugs for children specifically to treat schizophrenia, autism and bipolar disorder. But they are more frequently prescribed to children for other, less extreme conditions, including attention deficit hyperactivity disorder, aggression, persistent defiance or other so-called conduct disorders — especially when the children are covered by Medicaid, the new study shows.

Although doctors may legally prescribe the drugs for these "off label" uses, there have been no long-term studies of their effects when used for such conditions.

The Rutgers-Columbia study found that Medicaid children were more likely than those with private insurance to be given the drugs for off-label uses like A.D.H.D. and conduct disorders. The privately insured children, in turn, were more likely than their Medicaid counterparts to receive the drugs for F.D.A.-approved uses like bipolar disorder.

Even if parents enrolled in Medicaid may be reluctant to put their children on drugs, some come to rely on them as the only thing that helps.

"They say it's impossible to stop now," Evelyn Torres, 48, of the Bronx, said of her son's use of antipsychotics since he received a diagnosis of bipolar disorder at age 3. Seven years later, the boy is now also afflicted with weight and heart problems. But Ms. Torres credits Medicaid for making the boy's mental and physical conditions manageable. "They're helping with everything," she said.

 

Friday, December 11, 2009

Green Mental Health Care

Genita Petralli

Green Mental Health Care —
Reclaiming Lives From
Psychiatric Drugs

by Genita Petralli, Nutritional Biochemist

"My life is dedicated to reclaiming lives from psychiatric drugs and exposing psychiatry for what it is; a gang of white collar drug pushers robbing our society of every resource that supports it right down to our future; the children.

"As a scientist and licensed practitioner I want to educate all those interested in what is causing the epidemic mental health crisis of today, how to avoid it, how to get off of psych drugs if you are on them now, and why toxic drugs should not ever be called medicine."

Click here to read more.

 

Friday, December 04, 2009

Ever see a psychiatrist get his license revoked?

Today, the Florida Board of Medicine voted unanimously to revoke Emanuel John Falcone’s medical license.

He had sex with a patient.

 

See video here:

#1   http://www.youtube.com/watch?v=KS99TPmwWYI

#2   http://www.youtube.com/watch?v=uYU4R4hF_nI

 

Psychiatrist Emanuel Falcone

 

More stories and TV footage will be coming forth but the below links show what has been reported today.  

 

A few excerpts:

 

http://tinyurl.com/psych-sex

Florida Times Union

Florida State Prison psychiatrist's license stripped over past patient-sex relationship

In today’s hearing, Falcone’s effort to get his revocation reduced to probation and a fine, among other penalties, was rebuffed by the panel. He declined to be interviewed as he left the hearing and walked away with his head down and hands in his pockets.

 


 

http://www.panhandleparade.com/index.php/mbb/article/florida_department_of_corrections_admits_poor_judgement_in_hiring/mbb7720192/WMBB.com

WMBB.com

Florida Department of Corrections Admits Poor Judgement in Hiring
12/04/09

The Florida Department of Corrections admits its medical staff used poor judgment when they hired a psychiatrist at Florida State Prison, even though they knew his medical license had been revoked in New York for having sex with a mentally ill patient he was treating.

 

 


 

http://www.miamiherald.com/news/florida/AP/story/1365730.html

Medical license revoked for prison psychiatrist

The Associated Press

12.04.09

RAIFORD, Fla. -- A senior psychiatrist at Florida State Prison at Raiford will have his medical license revoked.

The Florida Board of Medicine voted unanimously Friday to revoke the license of Emanuel Falcone.

 

 


 

http://www.healthnewsflorida.org/index.cfm/go/public.articleView/article/15274

Florida Health News

Psychiatrist's license revoked

By Carol Gentry

12/4/2009

Falcone, 52, resigned when top officials at the Department of Corrections found out from a reporter for the Florida Times Union that his New York license was revoked last year. Authorities there had charged him with taking sexual advantage of a patient who had multiple personality disorder, an adult woman who had numerous childlike "alters."

 

Weekley said it was unfortunate that corrections officials reacted to "a high-profile media circus." Indeed, television cameras recorded the proceedings, an unusual event for an administrative board.

Thursday, December 03, 2009

Prison Psychiatrist Resigns

http://tinyurl.com/sex-with-patient

 

Florida Times Union

Raiford prison psychiatrist quits over sex with patient

By Paul Pinkham

Thursday, Dec. 3, 2009

 

A senior psychiatrist at Florida State Prison in Raiford quit Wednesday  after corrections officials were asked why he was hired even though New York revoked his medical license last year for  having sex with a mentally ill patient.

 

Emanuel John Falcone was hired for the $188,000-a-year position in September,  even after revealing his past to the person who interviewed him, prison officials said. Falcone, 52, also faces a pending recommendation, scheduled to be heard Friday, that his Florida license be revoked or suspended.

 

Department of Corrections Secretary Walter McNeil was unaware of any of that until the Times-Union called Tuesday with questions about why Falcone was hired, a department spokeswoman said.

 

“Once he learned about it, we started questioning Dr. Falcone, and he chose to resign,” said Gretl Plessinger.

 

She said she was unaware who else in the department knew of Falcone’s past.

 

A woman answering Falcone’s phone number in Fort Myers said, “I don’t think he’s going to be interested in talking to you,” before hanging up Wednesday afternoon. In his formal response to the New York Bureau of Professional Medical Conduct last year,  he admitted the sexual relationship but denied ever treating the woman, who suffers from multiple personality disorder.

 

He was not charged with a crime.

 

Jennifer Druitt,  executive director of the Florida Council Against Sexual Violence, said she was surprised the prison system would hire Falcone after he lost his license in New York and faces losing it in Florida. At best, she said, he exhibited serious problems with judgment.

 

According to the New York bureau, the woman began seeing Falcone’s girlfriend, a licensed clinical social worker, in her Manhattan office in 2003. The patient-relationship continued after the couple married and moved to Florida in 2005. Falcone’s wife would share the patient’s information with him, the New York bureau found. The woman and Falcone began communicating by phone, and he gradually took over her treatment.

 

In a case summary, a panel of New York physicians wrote that Falcone was “fascinated” by her alternative identities, some of which were children. Her actual age wasn’t in any of the reports.

 

Their sexual relationship began in 2006 when they got together in New York, the summary said. It continued with a weekend trip that year to swanky Captiva Island, near Fort Myers.

 

Falcone told the bureau he never considered his interactions with the woman to be treatment or therapy. But the panel rejected that argument in permanently revoking his license in September 2008 for professional misconduct, gross and repeated incompetence and negligence and failing to maintain medical records.

 

“He was too selfishly motivated and lost sight of his oath,” the panel said. “... We saw no remorse, no humility, no sign that he understood the great harm that he caused despite his attempt to present a speech that was supposed to convince us otherwise.”

 

The bureau found his actions toward the patient “predatory” and said he knew her illness left her vulnerable.

 

“He eventually exploited that vulnerability for his own purpose and satisfaction,” the panel wrote.

 

Florida’s Health Department began investigating last December,  including allegations that he didn’t notify Florida authorities about the New York revocation.

 

The department petitioned the Board of Medicine in April  for revocation or suspension of his Florida license. State law says having a license revoked by another jurisdiction is grounds for disciplinary action by the Board of Medicine.

 

In October, Falcone requested a hearing at the board’s Friday meeting in Orlando. The board could take any action it chooses, from a reprimand to revocation.

 

Monday, November 23, 2009

University of Florida psychiatrist arrested for DUI


 

 

Anderson

Psychiatrist Marcus Anderson

 

 

UF psychiatrist arrested for DUI
MATT HARRINGER, Alligator Contributing Writer
November 23, 2009


A resident psychiatrist at UF's College of Medicine was arrested early Sunday morning for driving drunk and failing to stop after hitting a pedestrian near Ben and Jerry's on University Avenue.
Marcus Anderson, 28, drove onto the sidewalk and hit 27-year-old law student Clay Hodges as he was leaving 101 Cantina, according to a police report.

 


Hodges said the vehicle hit his elbow and the side mirror smashed into his ribs.

 


After hitting Hodges, Anderson hit a stop sign, put his car in reverse and tried to drive away, according to the report.

 


Cameron Pettit, who watched the scene from his doorman post at 101 Cantina, said if the accident had happened five minutes earlier, 10 people waiting in a line to enter the bar would have been hit.
After being hit, Hodges said he was sore, but paramedics said nothing was broken.

 


"I was lucky," Hodges said.
Phone calls to Anderson were not returned Sunday. He was released without bail.

 

 

Wednesday, November 18, 2009

Pharma's $1.7 billion dollar internet marketing campaign

Take 3 minutes to watch this video and then pass along to your friends
 

Pharma's Drug Ads: From Million Dollar TV Ads to $1.7 Billion Internet Marketing Campaign

New Video and Blog from CCHR International

Kathleen Slatter-Moschkau
Kathleen Slattery-Moschkau

Click here for new video and blog.

Friday, November 13, 2009

Senator Asks For Data On Troops, Antidepressants

U.S. Senator Ben Cardin's letter is here: http://cardin.senate.gov/pdfs/milantidepressant.pdf

 

 

Nov 10, 2009

Senator Asks For Data On Troops, Antidepressants

WASHINGTON (AP) ― A Maryland senator has asked the Pentagon for information on how many troops in war zones have been prescribed antidepressants while they were deployed.

Democratic Sen. Ben Cardin sent a letter Tuesday to Defense Secretary Robert Gates expressing concern about how antidepressant drugs are being administered troops in Iraq and Afghanistan.

Cardin said he wanted to determine if the Defense Department is prescribing antidepressants appropriately and was concerned that there may be a connection between the use of those medications and the suicide rate among troops.

Cardin said the rate of active-duty suicides is greater than that of the U.S. population.

Thursday, November 12, 2009

Eli Lilly to pay Utah $24 million in settlement

Deseret News

Firm to pay Utah $24 million in settlement

Nov. 11, 2009

By Geoff Liesik

Pharmaceutical giant Eli Lilly and Co. has agreed to pay $24 million to settle a lawsuit filed by the Utah Attorney General's Office.

Attorney General Mark Shurtleff sued the company after a nearly four-year investigation revealed that Lilly concealed its knowledge of significant weight gain and obesity associated with the anti-psychotic medication Zyprexa. Investigators also showed that Lilly's sales representatives illegally promoted the drug for uses not approved by the U.S. Food and Drug Administration.

"We're not just asking them for money. We want their bad conduct to stop," Shurtleff said Wednesday while announcing the settlement.

"As part of the settlement agreement, there are corporate integrity responsibilities and remedial provisions that will continue to be monitored by the court to stop (Lilly's) harmful behavior."

Zyprexa is approved for the treatment of schizophrenia and certain types of bipolar disorder in adults. But authorities say that in 1999, Lilly's marketing arm that focuses on doctors who treat the elderly began encouraging physicians to prescribe the drug for dementia, Alzheimer's disease, agitation, aggression, hostility, depression and generalized sleep disorder without prior FDA approval. Lilly also trained its sales teams to avoid discussions with health-care professionals about the weight gain side effect, investigators said.

Shurtleff said his office's investigation, conducted in conjunction with the Utah Department of Health, showed there were 1,769 Medicaid patients in Utah over the age of 65 who took Zyprexa but never had a diagnosis of either schizophrenia or bipolar disorder.

Dr. David Sundwall, executive director of the state Health Department, said when he was presented with those numbers he knew they were inflated and agreed to lend his agency's support to the case. He said the timing of the settlement "couldn't be better."

"Due to our recent economic decline, we've had the highest increase ever in enrollment in Medicaid," Sundwall said. "We need funds to keep up with demand."

He added that Wednesday's announcement shouldn't be viewed as an indictment of drug companies.

"We do not intend to demonize the pharmaceutical industry," Sundwall said. "As a clinician, and even as a patient, I appreciate the research and development done by pharmaceutical companies in our nation. Because of newer and better drugs we prevent disease; we treat illness and sometimes cure it; we prevent unnecessary hospitalizations and surgeries."

Joe Steele, a private attorney who aided the state in its case, described the lawsuit as "righteous litigation."

"They did what we accused them of doing," he said, referring to Lilly. "Bringing the money back into the state to take care of the children who so badly need it and the people who so badly need the medical care that Medicaid provides is, I think, one of the most important things we can do."

The settlement is the largest in Utah's effort to hold drug companies accountable for illegal practices, according to Shurtleff.

The state is expected to receive approximately $20 million once contingency fees are paid to private attorneys who aided in the litigation. That money will be placed in the state's general fund for allocation by the Legislature.

Update on U.S. Health Care Reform bills

CCHR Update on U.S. Health Care Reform Bills

There are dozens of organizations that are objecting to provisions in the U.S. health care reform bills.  As the primary mental health watchdog organization, CCHR has been hard at work identifying the specific mental health provisions in these bills so we can inform the public of the very real risks of various aspects of these bills that clearly are designed to benefit the psycho/pharmaceutical industry, not the general public.  To read CCHR's analysis of the House Bill and two Senate Health Care Reform bills (which will soon be merged into one Senate bill), and to find out where all of this is heading before a final bill/vote is completed, click here.

Friday, November 06, 2009

"Science Pimping" Psychiatrist - Charles Nemeroff - criticized for taking millions from drugmakers


 
Comments can be made here: http://www.miamiherald.com/103/story/1319569.html   (short registration required) 
 
Bernard Carroll, former head of psychiatry at Duke University and once Nemeroff's boss, said parts of Nemeroff's work involved Paxil ...  ``Basically, he was doing basic science pimping for Paxil to produce talking points,'' Carroll told The Herald in an e-mail Thursday. ``All he ever produced was speculation but that was enough to satisfy Glaxo marketing. . . . I have been exposing his shenanigans for some years.''
 
Charles Nemeroff - Psychiatrist 
 
University of Miami hires controversial expert
The UM medical school hired a psychiatrist who has been criticized for taking millions of dollars from drugmakers.
Friday, November 6, 2009

Charles Nemeroff, an Atlanta psychiatrist who was the subject of a Senate investigation concerning huge sums he received from drug companies, has been named chairman of the psychiatry department at the University of Miami.

Last year Nemeroff, as the top psychiatrist at Emory University, was the focus of an investigation by Sen. Charles Grassley, R-Iowa, who said he was concerned about the millions the psychiatrist received from drug companies while conducting supposedly unbiased research for the National Institutes of Health on drugs made by the companies he was receiving money from.

On Thursday, Pascal Goldschmidt, dean of UM medical school, called Nemeroff ``an exceptional psychiatrist and an exceptional scientist who has one issue in which he recognizes he made a mistake,'' in not telling Emory how much he was getting from drug makers.

Goldschmidt said he had read investigative reports from Emory about Nemeroff's activities and Emory found nothing to indicate that payments the psychiatrist received had in any way influenced his research results.

Elsewhere, opinions are divided.

The former head of psychiatry at Duke University told The Miami Herald Thursday that Nemeroff was ``economical with the truth'' and his work can't be trusted, while the leader of the Columbia University psychiatry program said Nemeroff was a top-flight scientist and he had never seen any bias in his work.

For his own part, Nemeroff, 60, said he was excited to be coming to Miami. ``I think it's going to be a top-10 school.''

PAYMENT DISCLOSURE

Nemeroff's appointment comes at a time when healthcare reform bills in both the House and Senate have sections requiring healthcare providers to publicly reveal their payments to doctors.

In October 2008, the psychiatrist's activities made the front page of The New York Times after Grassley investigators found that Nemeroff -- ``one of the nation's most influential psychiatrists,'' according to The Times -- had received $2.8 million in consulting deals with drug makers over seven years and failed to report at least $1.2 million of that to Emory.

Based on Grassley's complaints, Nemeroff's work on a mayor NIH grant was suspended and Emery asked him to step down as chair of psychiatry while it studied his conduct.

The Atlanta Journal-Constitution reported that the Office of the Inspector General of the Department of Health and Human Services had launched an investigation into Nemeroff's activities. An OIG spokesman said it never confirms nor denies investigations. Nemeroff said he knew nothing about OIG looking at him.

According to published reports, the psychiatrist received between $800,000 to $1.2 million from GlaxoSmithKline while leading a major study into mood disorder drugs, including ones made by GSK.

Nemeroff said Thursday that the news reports had not made clear that his talks were on GSK drugs now on the market, while his research funded by NIH involved basic lab studies of GSK chemical compounds that were years away from market. That work did not promote GSK products, he told The Herald.

`SCIENCE PIMPING'

But Bernard Carroll, former head of psychiatry at Duke University and once Nemeroff's boss, said parts of Nemeroff's work involved Paxil, a GSK antidepressant. ``Basically, he was doing basic science pimping for Paxil to produce talking points,'' Carroll told The Herald in an e-mail Thursday. ``All he ever produced was speculation but that was enough to satisfy Glaxo marketing. . . . I have been exposing his shenanigans for some years.''

Jeffrey Lieberman, head of psychiatry at Columbia University, praised Nemeroff as a leading expert in ``basic neuroscience,'' studying underlying pathologies and proteins in the brain that cause mental illness. He said he had never detected ``any undue influence or bias'' in Nemeroff's research.

However, all the academics interviewed Thursday acknowledged that large payments to researchers were a concern. ``Of course, it creates problems,'' Carroll said.

At UM, Goldschmidt said it was important for researchers and pharmaceutical companies to work together to develop better drugs. He said limits of how much researchers should be allowed to receive are still being debated.

In June, the Pew Prescription Project gave UM a ``B'' on a scorecard designed to measure ethical policies on professors' relationship with the pharmaceutical industry.

REQUIREMENTS

UM is now in the process of strengthening its reporting requirements, said Goldschmidt, so that all outside professional work must be reported -- and the results will eventually be posted online for the public to see.

Those requirements will apply to Nemeroff, who starts at UM on Dec. 1, and all other medical school staffers.

In the past, Goldschmidt said, there was debate whether professors needed to report fees from drug makers for giving continuing medical education (CME) talks, which are supposed to be non-promotional. That became an issue in Nemeroff's case in Atlanta.

In an interview Thursday, Nemeroff said in retrospect he should have declared the CME payments he received from drug makers, but he viewed Emory standards as not requiring such revelations.

LETTER OF SUPPORT

In a letter to Grassley last December, Emory officials wrote: ``We do not believe that Dr. Nemeroff's participation in the compensated speaking arrangements with GSK in any way biased the research conducted under the grant.''

The letter said Nemeroff's talks on behalf of GSK were ``focused on medical education and were not product specific or promotional. . . . As you alleged, Dr. Nemeroff did not disclose substantial speaking fees from pharmaceutical companies to Emory. Under federal regulations and Emory's policies, we believe he should have done so, although both the regulations and our policies could have been clearer.''

Grassley responded in a letter that his staff's research found that Nemeroff's talks were promoting GSK products -- not educational -- and should have been reported.

Tom Johnson, former president of the CNN network and former publisher of The Los Angeles Times, said Thursday he was part of an Emory advisory board that examined Nemeroff's behavior and the university's ethics policies. The policies were ``confusing,'' Johnson told The Herald. They have since been modified. 

 

The "Business" of Drugs: Massive Weight Gain for Children on Antipsychotic Drugs Added to the Growing Side Effect List

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Dear Members,

The Wall Street Journal released a new study published in the Journal of the American Medical Association today, which noted that antipsychotic drugs, widely used in children, actually caused them to gain as much as 19 pounds on average after just 11 weeks on the medications.

And while weight gain can sometimes be seen as a relatively minor side effect – especially when compared to increased and even murderous aggression or the often reported suicidal tendency these exact drugs bring to adults and youth alike, the report noted the drugs propensity to cause the type of significant weight gain that could lead to diabetes and cardiovascular (heart) disease.

Known as the atypical antipsychotics, the direct correlation to significant weight gain adds to growing concerns about giving the medicines to patients under 18 years of age. The study's authors urged child psychiatrists to exercise more caution before deciding to prescribe, and recommends close monitoring of patients who do wind up taking these “wonder” drugs.

These powerful drugs are used to treat schizophrenia and bipolar disorder, but have faced growing scrutiny, not only because of proven side effect risks, but also because of the aggressive and often illegal re-marketing tactics by their makers that have helped make them the highest-selling class of drugs in the U.S.

The study results were fortuitously released in advance of Food and Drug Administration’s likely official authorization of these drugs for even younger patients. Atypical antipsychotics already have limited approval for youths, but doctors have been “free to prescribe them as they see fit” without any FDA authorization to do so and unfortunately they often give them to children and adolescents, say analysts and psychiatrists

Psychiatrists turned to the new drugs after they began going on sale in the 1990s because they didn't cause involuntary facial tics and other visually obvious cosmetic type problems that an earlier generation of these types of medicines did. Last year, the drugs collectively generated $14.6 billion in sales in the U.S., but a growing number of studies confirm that these new drugs have their own set of significant, yet often ignored, side effects.

"The weight gain is much larger than we thought," said Christoph Correll, the study's lead author, who is a psychiatrist and a scientist at the Feinstein Institute for Medical Research in Manhasset, N.Y. "It's massive, and it's the medication" that caused it, he said.

The JAMA study, conducted in 272 youths ages 4 to 19 years, is the largest and most definitive to date to establish a link between the drugs and weight gain, the authors said. Unlike earlier studies, it looked only at patients who hadn't previously taken the medicines.

The drugs examined were four top-selling atypical antipsychotics: Abilify, sold by Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co.; Risperdal from Johnson & Johnson; Seroquel from AstraZeneca PLC; and Zyprexa from Eli Lilly & Co.

Interestingly, the study found that, of the drugs studied, Zyprexa caused the most weight gain. Over 11 weeks of use, children on Zyprexa gained the most weight on average, nearly 19 pounds, or a 15% increase. The Zyprexa drug was also found to significantly raise levels of blood sugar, cholesterol, insulin and triglycerides, which can lead to diabetes and heart problems.

Patients taking the other three drugs gained from 10 to 13 pounds on average, according to the study and the negative impact on users' blood sugar and other metabolic levels varied, depending on the drug.

In January, Lilly agreed to pay $1.42 billion to settle a federal probe into alleged improper re-marketing of Zyprexa. Other pharmaceutical companies have also come under fire for allegedly promoting off-label uses of atypical antipsychotics and playing down or withholding information on their adverse side effects.

Fortunately, as concerns about the side effects have mounted, prescriptions for children have slowed down. Dr. Correll encouraged child psychiatrists to be even more careful about giving the drugs to youths and, when they do, to encourage a healthy diet and to check weight and metabolic levels every three months.

The FDA will soon decide whether to approve younger patients' use of Seroquel, Zyprexa and Geodon, another atypical antipsychotic. (note: Geodon wasn't part of the study because, until now it's not often used in new patients and too few users were even enrolled in the trials according to Dr. Corell).

You can call the FDA and let them know your thoughts about whether they should authorize any of these antipsychotic products to be remarketed to children in light of recent revelations. You can also suggest more in-depth trials be conducted to determine additional side effect risks.

Call 1-888-463-6332) Press 2, followed by 1 for information, then select #3 for drug products in order to log your complaint and/or suggestions.

You can also write to the Wall Street Journal reported who wrote this story to thank him for releasing this information in advance of any FDA approval to remarket these powerful drugs to children. We do not recommend promotion of any kind however, you can suggest related issues and possible follow up stories. The reporter is Jonathan Rockoff and he can be reached by email at Jonathan.Rockoff@wsj.com

 

Friday, October 30, 2009

A Mother's Hope - Little boy Rescued from Psych Drug Cocktail

 

 

Channel 7 - WSVN-TV (Miami/Fort Lauderdale)

A Mother's Hope

7 News Investigation

Reported and Produced by: Patrick Fraser

 

Patrick Fraser

Earlier this year a 7-year-old boy in state custody prescribed mind altering drugs threatened to kill himself, then he did. This summer another child on powerful drugs also threatened to kill himself, his mother called Help Me Howard, what happened after that? Tonight here is Patrick Fraser with a story we call a mothers hope.

WSVN -- When I first met Anthony he was not the child who had been described to me.

Hope Estrada, Anthony's Mother: "I've been told by some doctors in Key West that I'm raising the next Charles Manson, OK?"

One doctor said he was mentally retarded, another said he was bi-polar. He has been sent to psychiatric hospitals, slapped in straight jackets and given mind altering drugs. The affect of it all on an 8-year-old is not surprising.

Hope Estrada: "The other day when he was Baker Acted and they restrained him, he told me, 'Mom, I want to kill myself, I don't want to live like this, I can't control myself.'"

Hope says she was told a few weeks ago, by the State of Florida the best solution is to give up on Anthony.

Hope Estrada: "Basically I've been told, you know, move on with your life, and give Anthony to the state and let him become a ward of the state. I'm not going to do that, I refuse to give in."

And so, after contacting dozens of people from the president on down she called Help Me Howard and we knew this case required an expert.

Andrea Moore

Howard Finkelstein: "I knew that Anthony needed a lawyer that was an expert in both DCF how kids were treated medications, mental health issues and the only person that came to mind was the best person was Andrea Moore."

Andrea Moore, a noted child advocate, agreed to take Anthony's case for free. It took weeks of her time, but as she met with Hope and Anthony, interviewed specialists and dug through his medical records, many things bothered her.

Andrea Moore, Child Advocate: "They didn't know his IQ. This is the place he's been three times in three years, they didn't know his IQ, and he's very smart, yet some of the paperwork that I saw, said he was mentally retarded. The conflicting information in the records tells me that people didn't really carefully read the records."

The heavy doses of three mind altering drugs used on adults troubled Andrea, even more frightening she believes Anthony may not have even needed those drugs.

Andrea Moore: "I started to wonder if we were dealing with a head injury, as opposed to a psychiatric, purely psychiatric situation."

Turns out Andrea was right, Anthony did have a prior head injury. He fell and fractured his skull when he was eight months old, but he had never had a brain scan, instead private doctors hired by the state concluded he had psychiatric problems.

Patrick Fraser: "Why did it take you to notice this, when he is under the care of a psychiatrist, and has seen more doctors then you and I have probably seen in our lives combined? Why did it take you coming in from the outside to see that?"

Andrea Moore: "This is a terrible question Patrick."

Andrea is modest and polite, Howard is blunt.

Howard Finkelstein: "They had diagnosed him wrong, they treated him wrong, and as a result of the misdiagnosis and mistreatment, I believe they were making him worse."

With DCF's help, Andrea got Anthony off the powerful drugs and moved from the psychiatric hospital. To Jackson Memorial's highly touted brain injury center.

Patrick Fraser: "Good to see you my man."

Today Anthony is getting the evaluations Andrea thinks he needs, and our investigation is bringing changes. When he was put in one psychiatric hospital Hope was forced to sign this letter that says if Hope has complaints about treatment or abuse she would not report it to DCF.

Jacqui Colyer, DCF Regional Director: "That I think is what keeps DCF on its feet."

When DCF saw the document they moved quickly.

Jacqui Colyer: "We have spoken with all of our provider agencies just to let them know that they can not tell families when to call or not to call us, because that is a part of their rights."

DCF also applauded Hope for fighting so hard for her son, but they say she did misunderstand one thing, that the state would have only taken custody of Anthony temporarily, not permanently, but thing is indisputable without Hope, Anthony was doomed.

And of course Hope and Anthony could not have done it without Andrea Moore.

Howard Finkelstein: "Andrea gave us her time her energy and her expertise and she fought along with Hope to save Anthony, you and I, we were just along for the ride."

Got to see a little boy get a chance to just be a normal little boy.

Hope to Patrick: "Thank you. God bless you, because if it wasn't for you, or Andrea, or Howard, my son would not get the help he needs Patrick, you are my guardian angel. I swear to God you are Anthony's guardian angel and I owe you so much for this, I really really do."

Finally Hope is wrong, Anthony has hope because of his mother's hope

Patrick told me Anthony called him the other day and said he would really like to get a dog to make sure Patrick didn't forget Anthony. faxed a picture of the kind of dog he wants he is getting better all right.