Jul19

Heart Warning Added to Label on Popular Antipsychotic Drug

by Administrator on July 19th, 2011 at 1:27 PM
Posted In: Antipsychotic, FDA, Fraud, News, Big Pharma, AstraZeneca, Seroquel

By DUFF WILSON
AstraZeneca is adding a new heart warning to the labels of Seroquel, its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday.

The revised label, posted without fanfare last week on the F.D.A. Web site, says Seroquel and extended-release Seroquel XR “should be avoided” in combination with at least 12 other medicines linked to a heart arrhythmia that can cause sudden cardiac arrest.

Sandy Walsh, a spokeswoman for the F.D.A., said the statement was only a precaution for doctors, and should not be considered a complete ban against prescribing Seroquel with the other drugs.

Ms. Walsh said the label was changed after the F.D.A. received new information about reports of arrhythmia in 17 people who took more than the recommended doses of Seroquel. Though it should not be a problem at a normal dosage, she said, it may still be good advice to avoid using the drugs together.

The arrhythmia, known as prolongation of the QT interval, referring to two waves of the heart’s electrical rhythm, is estimated to cause several thousand deaths a year in the United States.

As AstraZeneca prepares to report its second-quarter earnings at the end of this month, it faces additional scrutiny this week. The F.D.A. is considering the London-based company’s dapagliflozin, a proposed diabetes drug with Bristol-Myers Squibb, and is expected to decide soon on Brilinta, an anticoagulant. The company is facing the loss of patents for Seroquel next year and for the heartburn drug Nexium in 2014.

Seroquel is one of the top-selling drugs in the world, at $5.3 billion last year, including $3.7 billion in the United States. Introduced in 1997, it has been approved for schizophrenia, bipolar disorder and severe depression. Seroquel has caused legal problems for AstraZeneca, including a $520 million payment in 2009 to settle government charges of illegal marketing. Thousands of lawsuits are pending over side effects like diabetes.

The previous Seroquel labels had mentioned the risk of a prolonged QT interval, but had not identified other drugs to avoid, Stephanie Andrzejewski, a spokeswoman for AstraZeneca, said Monday. The new warning also is separated from other warnings and precautions on the label, she said, “to provide some additional guidance to physicians” treating patients ”who are already at risk of QT prolongation.”

The new warning will be added to printed labels as soon as possible, Ms. Andrzejewski said.

The new label lists the other drugs to avoid as antiarrhythmic drugs like quinidine, procainamide, amiodarone and sotalel; antipsychotic drugs like ziprasidone, chlorpromazine and thioridazine; antibiotics like gatifloxacin and moxifloxacin; the anti-infective drug pentamidine; and synthetic opioids like levomethadyl acetate and methadone. The label also raises caution about use by the aged and people with heart disease.

James J. Pepper, a lawyer in Pennsylvania who is involved in drug litigation, has been arguing for months in letters to government officials that Seroquel has a potentially deadly interaction with methadone in regard to the QT interval.

“This is a huge, huge step,” Mr. Pepper said of the label change, though he said he thought it should be stronger.

Ms. Walsh said the F.D.A. action was unrelated to Mr. Pepper’s arguments.

Three months ago, Dr. Janet Woodcock, director of the F.D.A. Center for Drug Evaluation and Research, rejected those arguments in a letter to the Project on Government Oversight, a nonprofit group in Washington, which had also raised the issues. Dr. Woodcock wrote that a thorough agency review had found it “exceedingly unlikely” that patients faced an unreasonable risk from the interaction between Seroquel and methadone. The review found only one death that was probably caused by the interaction, she wrote.

Dr. Woodcock concluded that the F.D.A. would take no action to change the label. Ms. Walsh said that conclusion was still correct, because the F.D.A. had found no biological basis for a problem or unusual numbers of deaths at normal dosages.

Methadone use and deaths have increased drastically in recent years as more doctors prescribe it for chronic pain. The number of methadone prescriptions for pain in the United States rose to 4.3 million in 2010 from 2.2 million in 2006, IMS Health, an industry data firm, said Monday. The use for pain has surpassed that for heroin withdrawal and maintenance.

URL: http://www.nytimes.com/2011/07/19/health/19drug.html?_r=1

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Jul08

Psychiatrist Pleads Guilty in $200 Million Medicare Kickback Scheme

by Administrator on July 8th, 2011 at 9:37 AM
Posted In: Fraud, Medicare, News, Psychiatrist

By Jorgen Wouters
A Florida psychiatrist pleaded guilty last week for his role in a health care scam that resulted in the submission of more than $200 million worth of bogus claims to Medicare, the Department of Justice, the FBI and the Department of Health and Human Services (HHS) announced.

Dr. Alan Gumer, 64, of Tamarac, Fla., pleaded guilty to one count of conspiracy to commit health care fraud after being charged on Feb. 15, 2011, along with 19 others involved in the scheme, on various counts of health care fraud, money laundering and other offenses.

Gumer was a psychiatrist at American Therapeutic Corporation (ATC), a Miami-based corporation that supposedly operated partial hospitalization programs (PHPs) in seven locations throughout South Florida and Orlando. Co-defendants included ATC; its management company, Medlink Professional Management Group Inc.; and the owners and lead manager of ATC, Medlink and the American Sleep Institute (ASI).

PHPs administer intensive treatment to patients suffering from severe mental illness, and Gumer admitted signing evaluations, notes and other medical documents for patients he knew didn’t need the intensive — and expensive — treatment for which ATC billed Medicare.

Gumer admitted signing papers without examining the patients or even writing and reading the statements he was signing. He also confessed to writing prescriptions for unnecessary psychiatric medications in order to fool Medicare into believing the patients qualified for PHP treatment.

The crooked doctor also referred hundreds of ATC patients to a related company and co-conspirator, ASI, for pointless diagnostic sleep disorder testing. Gumer’s co-defendants, ATC’s owners and operators, paid kickbacks to owners and operators of assisted living facilities (ALFs), halfway houses and patient brokers in exchange for ineligible patients which ATC and ASI could use to defraud Medicare. “Patients” sometimes received a cut of the kickbacks as well.

Overall, the ATC and ASI paid out millions of dollars in kickbacks in exchange for bogus Medicare beneficiaries who didn’t qualify for PHP services to attend illegitimate treatment programs so ATC and ASI could swindle Medicare for more than $200 million in unnecessary medically services.

Gumer’s role in the scheme was responsible for $19.3 million in fraudulent Medicare billing alone, and he faces a maximum of 10 years in prison and a $250,000 fine. Gumer’s sentencing is scheduled for January 2012.

ATC, its owners, and the lead manager of ATC, Medlink and ASI were charged with various counts of health care fraud, money laundering and other offenses in a separate superseding indictment unsealed on Feb. 15, 2011.

Two of the three ATC owners and the lead manager, as well as both ATC and Medlink, have pleaded guilty to more than $200 million in fraudulent Medicare billing and are scheduled for sentencing in September 2011. The trial of the third owner charged is scheduled to begin in August of this year. The remaining 17 co-defendants named in the indictment in which Gumer was charged are scheduled to stand trial in November 2011.

The case was brought as part of the Medicare Fraud Strike Force, supervised by the Criminal Division’s Fraud Section and the U.S. Attorney’s Office for the Southern District of Florida. Since its inception in March 2007, the Medicare Fraud Strike Force has charged more than 1,000 defendants who fraudulently billed Medicare for more than $2.3 billion.

To learn more about the Health Care Fraud Prevention and Enforcement Action Team (HEAT), go to www.stopmedicarefraud.gov.

URL: http://www.walletpop.com/2011/07/08/psychiatrist-pleads-guilty-in-200-million-medicare-kickback-sch/

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Jun17

Elmira psychiatrist to lose license

by Administrator on June 17th, 2011 at 2:34 PM
Posted In: AntiAnxiety, Antidepressants, Fraud, Big Pharma, Lithium, Abuse, Neglection, News, Psychiatrist, Psychiatry, Big Pharma, Biovail, Wellbutrin XL, Big Pharma, Pfizer, Xanax

Written by
G. Jeffrey Aaron

Misconduct charges include accepting kidney from patient

The New York State Health Department has revoked the license of an Elmira psychiatrist who has admitted charges of misconduct including accepting a kidney from a patient.

Dr. Carlos Delos-Reyes received his license to practice medicine in New York in March 1987. His license will be permanently restricted, effective June 21, and he will be prohibited from practicing in New York State.

According to a statement of charges issued by the state Board for Professional Medical Conduct, Delos-Reyes provided psychiatric care to patients at St. Joseph’s Hospital in Elmira, Family Services of Chemung County Mental Health Clinic or at the patients’ homes.

The misconduct charges filed against him include gross negligence, moral unfitness, willfully making a false report and failure to maintain adequate records for each patient.

» Between January 2010 and October 2010, Delos-Reyes failed to document a patient’s psychiatric, drug and alcohol use histories, and didn’t notice the patient’s adverse reaction to lithium, a mood stabilizing drug that Delos-Reyes prescribed without first evaluating the patient’s baseline kidney and thyroid function. Delos-Reyes was also charged with prescribing Xanax, used to treat anxiety attacks, without documenting the prescription. He also transcribed a prescription for Wellbutrin, an antidepressant, in the patient’s medical records but didn’t actually prescribe the medication.

» Between December 2008 and October 2009, Delos-Reyes failed to coordinate his treatment of a patient with her therapist, did not appropriately follow up on the patient’s levels of Valproic acid, a mood stabilizer used to treat conditions such as epilepsy, and did not refer the patient for metabolic lab studies.

» Between November 2005 and April 2009, Delos-Reyes accepted a kidney from a patient while serving as the patient’s psychiatrist. He also prescribed several medications for the patient without adequate medical justification, failed to document the prescriptions, and, in one instance, allowed the patient to write his own prescription. He was also charged with keeping inadequate medical records for the patient.

» From August 2005 to April 2008, Delos-Reyes failed to consult a patient’s primary care physician before treating the patient for hypersomnia, a disorder characterized by excessive amounts of sleepiness, failing to maintain an appropriate medication list for the patient and allowing the patient to complete the physician’s section of his behavioral health intake evaluation.

» From January 2004 to February 2009, Delos-Reyes did not perform an adequate psychiatric evaluation of a patient and failed to refer the patient for lab work to monitor his blood glucose and triglyceride levels.

URL:  http://www.stargazette.com/article/20110616/NEWS01/106160393/Elmira-psychiatrist-lose-license

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Jun13

Kissimmee police arrest psychiatrist, 15 others in sex sting

by Administrator on June 13th, 2011 at 7:41 PM
Posted In: News, Psychiatrist

Henry Pierson Curtis, Orlando Sentinel
4:58 PM EDT, June 13, 2011

A local psychiatrist was arrested along with more than a dozen others in an internet sex sting run by Kissimmee police last week, records show.

Dr. Ramaro Makkena, who has a child-and-adolscent practice on West Vine Street, was arrested Friday on prostitution-related charges after entering a decoy house set up for the week-long investigation, according to police.

“Prostitution can bring with it drug related crimes, robbery and burglary,” Police Chief Fran Iwanski said in a statement released Monday. “By conducting operations like this one, we are taking steps on curtailing these types of crimes within the City of Kissimmee.”

Besides prostitution, detectives targeted unlicensed contractors by trying to lure them to the undisclosed residence to make repairs, the report stated.

“The detectives had all the appliances in the home inspected by a master electrician to ensure they were working properly. The detectives then unplugged the dryer and placed service calls to handyman services on the dryer,” the report stated. “The elderly decoy would explain to the handyman the dryer was not working.”

Javier Medina, 46, was accused of fraud after spending an hour taking apart a clothes dryer, putting it back together and charging $60 without explaining his repairs, according to the report.

Police sent a recommendation that he be charged with organized fraud less than $300 by the Orange-Osceola State Attorney’s Office.

“On the positive side, handyman John Deja plugged in the dryer and gave the decoy a reduced service call rate. Mr. Deja was contacted by the detectives and was commended for his honesty,” the report said.

“It is important to hire only licensed, reputable contractors to do work in your home,” Iwanski said. “The Better Business Bureau is an excellent tool to use when deciding who is trustworthy enough to allow into your home.”

Dr. Makkena, who charged with assignation of prostitution and entering a dwelling for prostitution, was released Friday on $500 bail from the Osceola County Jail. He could not be reached immediately Monday afternoon at his office.

Fifteen others were arrested on similar charges, according to police.

hcurtis@tribune.com or 407-420-5257

URL: http://www.sun-sentinel.com/news/local/breakingnews/os-prostitution-sex-sting-craigslist-20110613,0,1658874.story

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Jun10

Accused child pyschiatrist’s wife testifies

by Administrator on June 10th, 2011 at 11:59 AM
Posted In: Abuse, Child abuse, Fraud, News, Psychiatrist, sex offenders, Abuse, Sexual assault, Abuse, Sexual harassment

By Diana Samuels

Daily News Staff Writer
Posted: 06/09/2011 06:12:59 PM PDT
Updated: 06/10/2011 12:11:49 AM PDT

The wife of Dr. William Ayres, a once-renowned child psychiatrist now accused of molesting several of his young male patients, testified in court Thursday that her 79-year-old husband can’t remember conversations, mixes up his words and once forgot his son’s name.

“He asks a question, he asks the same question 10 minutes later,” Solveig Ayres said during her husband’s competency trial, which began this week in San Mateo County Superior Court.

Defense attorney Jonathan McDougall is seeking to prove that his client suffers from Alzheimer’s-related dementia to such a degree that he is not competent to stand trial again on nine counts of lewd and lascivious conduct with minors under the age of 14.

Several of the doctor’s former patients — now in their 20s and 30s — claim he molested them during physical and genital exams he conducted as part of psychiatry sessions. Ayres was prosecuted for the alleged crimes in 2009, but a jury could not agree on a verdict and a mistrial was declared. The district attorney’s office announced in August 2009 it would refile charges, just a month after the first trial ended.

In opening statements Thursday, Deputy District Attorney Melissa McKowan said she does not dispute that Ayres suffers from dementia. But she said he is capable of understanding the legal proceedings well enough to aid in his own defense. She told jurors that two court-appointed doctors will testify that Ayres is competent.

In
a competency trial, the burden of proof falls on the defense to prove that the defendant is incompetent, she added.

“I will never disagree with the fact that he has some cognitive impairment,” McKowan said. “That is going to be obvious. … But the fact that he is suffering from this mental defect does not mean he cannot stand trial for the crimes he is accused of.”

McDougall said he plans to call as many as seven doctors to the witness stand to cast doubt on Ayres’ competency.

“How is that person that is not able to remember the name of his son, able to function in the legal world?” McDougall asked during his opening statement.

Solveig Ayres, the first witness called by the defense, said her husband began worrying about his memory at the end of the 2009 trial — he couldn’t remember former patients who testified.

“He said, ‘There’s something wrong in my brain,’” Solveig Ayres said.

His condition has worsened since then, she said. William Ayres could not remember what time the judge had told them to be at court the day before. During meetings with McDougall to talk about the case, Solveig said she takes notes and reviews them with William to remind him what was discussed.

On one occasion last December, he couldn’t remember his son’s name, she testified.

Lately, she added, he has been mixing up his words. For example, while talking with her about the Russian composer Sergei Rachmaninoff, her husband said “Republican” instead of “Rachmaninoff.” Solveig testified that William makes lists of the words he switches and tries to find a correlation between them.

Under cross-examination, Mc-Kowan portrayed that as an indication that William Ayres is well enough to be aware that he is making mistakes and is trying to figure out why.

“So he will think rationally and logically even though, at a moment in time, he switched a word?” she asked Solveig Ayres.

The trial is scheduled to resume on Monday.

Email Diana Samuels at dsamuels@dailynewsgroup.com.-

URL: http://www.mercurynews.com/breaking-news/ci_18242724?nclick_check=1

Related stories: Ayres’ Dementia Too Severe For Him To Face Molestation Charges

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