In Shift, Feds Target Top Execs for Health Fraud

Associated Press
May 31, 2011
WASHINGTON (AP) — It’s getting personal now. In a shift still evolving, federal enforcers are targeting individual executives in health care fraud cases that used to be aimed at impersonal corporations.
The new tactic is raising the anxiety level — and risks — for corporate honchos at drug companies, medical device manufacturers, nursing home chains and other major health care enterprises that deal with Medicare and Medicaid.
Previously, if a company got caught, its lawyers in many cases would be able to negotiate a financial settlement. The company would write the government a check for a number followed by lots of zeroes and promise not to break the rules again. Often the cost would just get passed on to customers.
Now, on top of fines paid by a company, senior executives can face criminal charges even if they weren’t involved in the scheme but could have stopped it had they known. Furthermore, they can also be banned from doing business with government health programs, a career-ending consequence.
Many in industry see the more aggressive strategy as government overkill, meting out radical punishment to individuals whose guilt prosecutors would be hard pressed to prove to a jury.
The feds say they got frustrated with repeat violations and decided to start using enforcement tools that were already on the books but had been allowed to languish. By some estimates, health care fraud costs taxpayers $60 billion a year, galling when Medicare faces insolvency.
“When you look at the history of health care enforcement, we’ve seen a number of Fortune 500 companies that have been caught not once, not twice, but sometimes three times violating the trust of the American people, submitting false claims, paying kickbacks to doctors, marketing drugs which have not been tested for safety and efficacy,” said Lewis Morris, chief counsel for the inspector general of the Health and Human Services Department.
“To our way of thinking, the men and women in the corporate suite aren’t getting it,” Morris continued. “If writing a check for $200 million isn’t enough to have a company change its ways, then maybe we have got to have the individuals who are responsible for this held accountable. The behavior of a company starts at the top.”
Lawyers who represent drug companies say the change has definitely caused a stir, but the end result is far from certain.
“People are alarmed,” said Brien O’Connor, a partner in the Boston office of Ropes Gray. “They want to know what facts and circumstances would cause the Justice Department to indict someone who hadn’t even known about the misconduct. They are doing all they can to achieve compliance.”
Others say high-powered corporate targets won’t go meekly.
“If the government does continue to press its campaign against individuals, we will see the limits of the government’s theories tested,” said Paul Kalb, who heads the health care group at the law firm of Sidley Austin in Washington. “In my mind, there is a very important open question as to whether individuals can be held criminally culpable or lose their jobs simply by virtue of their status.”
Although the Obama administration has increased scrutiny of corporate America generally, this shift in health care enforcement seems to have come up from the ranks, government and corporate attorneys say.
Investigators and lawyers at the HHS inspector general’s office, the Justice Department and the Food and Drug Administration started moving more or less independently toward holding executives accountable. Morris outlined the inspector general’s position in congressional testimony this spring, saying his office will use its power judiciously.
A test case is playing out with an 83-year-old drug company chief executive, Howard Solomon of New York City-based Forest Laboratories. Forest makes antidepressants, blood pressure drugs and other medications. Last month, the inspector general’s office notified Forest that Solomon could potentially be banned from doing business with federal programs.
The power to ban or “exclude” an individual rests with the inspector general. It’s routinely applied to low-level violators, but rarely to people of Solomon’s rank. In the industry, they call it the “death penalty.”
Last year, a Forest subsidiary pleaded guilty to criminal charges as part of a settlement with the Justice Department in which the company also agreed to pay $313 million to resolve long-running investigations. Prosecutors charged that Forest deliberately ignored an FDA warning to stop distributing an unapproved thyroid drug, promoted the use of an antidepressant in treating children although it was only approved for adults and misled FDA inspectors making a quality check at a manufacturing plant.
The company said it had considered the case closed. But then came the inspector general’s letter.
“No one has ever alleged that Mr. Solomon has done anything wrong and excluding him would be completely unjustified,” Herschel Weinstein, Forest’s general counsel, said in a statement. “In prior cases where a senior executive has been excluded, that individual has been accused of wrongdoing and ultimately has either been convicted of or (pleaded) guilty to a crime.”
Forest is fighting the move to ban Solomon. The inspector general’s office refused to comment on the case, and no final decision has been made. In congressional testimony, Morris said that when there is evidence an executive knew or should have known about misconduct, the inspector general “will operate with a presumption in favor of exclusion of that executive.”
Separate from the inspector general’s power to ban, the FDA has resurrected something called the “Park Doctrine,” which makes it easier for prosecutors to bring criminal charges against an executive.
The doctrine, stemming from a 1970s Supreme Court case, allows the government to charge corporate officers in the chain of command with a criminal misdemeanor. They could face up to a year in prison and fines if they had the authority and responsibility to prevent, detect or resolve misconduct affecting the public welfare but failed to do so.
It’s making an entire industry nervous.
Read article here: http://www.google.com/hostednews/ap/article/ALeqM5jIGsUXYEAKspVXkeAdCDNumbbNFA?docId=d620a807289f47a6b01dfe728972a0b3

Patients who use anti-depressants are more likely to suffer relapse, researcher finds

Science Daily
July 19, 2011

Patients who use anti-depressants are much more likely to suffer relapses of major depression than those who use no medication at all, concludes a McMaster researcher.

In a paper that is likely to ignite new controversy in the hotly debated field of depression and medication, evolutionary psychologist Paul Andrews concludes that patients who have used anti-depressant medications can be nearly twice as susceptible to future episodes of major depression.

Andrews, an assistant professor in the Department of Psychology, Neuroscience & Behaviour, is the lead author of a new paper in the journal Frontiers of Psychology.

The meta-analysis suggests that people who have not been taking any medication are at a 25 per cent risk of relapse, compared to 42 per cent or higher for those who have taken and gone off an anti-depressant.

Andrews and his colleagues studied dozens of previously published studies to compare outcomes for patients who used anti-depressants compared to those who used placebos.

They analyzed research on subjects who started on medications and were switched to placebos, subjects who were administered placebos throughout their treatment, and subjects who continued to take medication throughout their course of treatment.

Andrews says anti-depressants interfere with the brain's natural self-regulation of serotonin and other neurotransmitters, and that the brain can overcorrect once medication is suspended, triggering new depression.

Though there are several forms of anti-depressants, all of them disturb the brain's natural regulatory mechanisms, which he compares to putting a weight on a spring. The brain, like the spring, pushes back against the weight. Going off antidepressant drugs is like removing the weight from the spring, leaving the person at increased risk of depression when the brain, like the compressed spring, shoots out before retracting to its resting state.

"We found that the more these drugs affect serotonin and other neurotransmitters in your brain -- and that's what they're supposed to do -- the greater your risk of relapse once you stop taking them," Andrews says. "All these drugs do reduce symptoms, probably to some degree, in the short-term. The trick is what happens in the long term. Our results suggest that when you try to go off the drugs, depression will bounce back. This can leave people stuck in a cycle where they need to keep taking anti-depressants to prevent a return of symptoms."

Andrews believes depression may actually be a natural and beneficial -- though painful -- state in which the brain is working to cope with stress.

"There's a lot of debate about whether or not depression is truly a disorder, as most clinicians and the majority of the psychiatric establishment believe, or whether it's an evolved adaptation that does something useful," he says.

Longitudinal studies cited in the paper show that more than 40 per cent of the population may experience major depression at some point in their lives.

Most depressive episodes are triggered by traumatic events such as the death of a loved one, the end of a relationship or the loss of a job. Andrews says the brain may blunt other functions such as appetite, sex drive, sleep and social connectivity, to focus its effort on coping with the traumatic event.

Just as the body uses fever to fight infection, he believes the brain may also be using depression to fight unusual stress.

Not every case is the same, and severe cases can reach the point where they are clearly not beneficial, he emphasizes.
###

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German Psychiatric Association admits Nazi Psychiatrists Role in Holocaust-era Crimes

Psych Crime Reporter translation of a November 26, 2010 article from the German online magazine Focus.de The original article can be seen here.]
65 years after the end of the Third Reich, the German association of psychiatrists faces up to its dark history—at last. Only today it offers an apology for its crimes committed during the period of the National Socialism.
Only now the German association of psychiatrists officially faces up to its gruesome crimes during the period of the Third Reich. In a commemoration for the victims and the expelled Jewish doctors, president Frank Schneider offers an apology for the atrocities committed.
FOCUS: In this commemoration at the congress of the Deutsche Gesellschaft für Psychiatrie, Psychotherapie und Nervenheilkunde (German Association of Psychiatry, Psychotherapy and Neurology) you are about to offer an apology for the crimes committed by psychiatry during the period of the National Socialism. Why hasn’t this long been done?
Frank Schneider: I don’t know why we talk about this only now. We are at a loss of words why an event like this one can take place only now. It’s almost impossible to explain, there is no justification for it.
In our association DGPPN we refer to 160 years of tradition, and it existed even in the Third Reich. The president at that time was doing research on racial hygiene and propagated it externally. Inconceivable crimes were being done. And still, after 1945, we didn’t support the victims but we had a part in their renewed discrimination and disadvantage. This darkest part of our history has been shunned and repressed much too long. The persistent silence is also a debasement for the victims. We are ashamed of that.
Today we are going to apologize and ask for reconciliation. A lot of the victims are dead by now, and insofar our solicitation is too late. But maybe it isn’t too late for the people still alive and their descendants – and for all mentally ill people today, for today’s psychiatrists and for the association itself.
FOCUS: How exactly does your association face up to the crimes?
Schneider: To begin with, we decided to change the articles of association. Paragraph 1 now firmly states that the association commemorates the victims and is responsible for what happed back then. And that we are responsible that something like this will never ever happen again.
Furthermore an independent international commission of four outstanding science historians is engaged to research our association’s history in the Third Reich. We provided 150,000 Euros (about 200,000 USD) to accomplish that, and we stipulated to announce the results of the study no matter what comes out of it.
Subsequently we plan to do another study in order to clear up the postwar years, i. e. the period of the cover-up and the repression which went on until the 1980s.
FOCUS: What kind of victims do you commemorate?
Schneider: First of all the approximately 2,000 Jewish psychiatrists who were forced to emigrate and therefore lost their home and their belongings. Then also the people who suffered enforced sterilization and those who were killed.
We also commemorate the victims who beared misery due to psychiatric research, who were maimed or murdered.
FOCUS: You, as president, have made the subject of the National Socialism period to the core theme of this congress and your term in office. Why did you do that?
Schneider: The subject of psychiatry’s Nazi history is very important to me personally. I have always been aghast and wondered: How can psychiatrists kill their patients? And this has been done very extensively either by themselves or they have had other people do it.
Including the East European countries there were all in all about 300,000 mentally ill people whose psychiatrists caused their deaths. That’s incredible.
FOCUS: What kind of reactions did you encounter inside your association?
Schneider: I thought nobody liked the subject but the responses have been positive uniformely. I was surprised and happy about that. I just watered the seed. It was long overdue.
FOCUS: Weren’t there admonishers earlier that fought for a clearing-up and a confession?
Schneider: There was Professor Gerhardt Schmidt, head of psychiatry in Lübeck, Germany, who directly after 1945 came to a clinic where patients starved to death, meaning they were killed. He wrote a very outright book about these conditions. I read it as a student and I was highly impressed at the time. This man named Schmidt was not able to publish his book for 20 years because he was facing a Mafia of psychiatrists who didn’t want anybody to foul their nest. In the 1980s it was a moment of glory in our association to award him with a medal for it.
FOCUS: How come psychiatry’s atrocities have been ignored for so long?
Schneider: It was hushed up and repressed. After the war, three renowned psychiatrists, who made medical estimates for enforced sterilizations and who decided upon life or death, became presidents of our association and even honorary members. One of these former presidents, professor Ehrhardt from Marburg, Germany, was also the leading secretary. He wrote a booklet about the history of German psychiatry and its associations. It isn’t thick. It says that psychiatrists of the Third Reich had no knowledge of what was going on and they didn’t have anything to do with it and they found it all really terrible. This is an official document of the association.
What’s even worse: In the 1960s, when the question arose whether people who suffered forced sterilization should get any indemnity, Ehrhardt and also other psychiatrists appeared as an authority on the subject in the Bundestag (Lower House of German Parliament). In an advisory committee they declared that forced sterilization was compliant to the rules at that time and it was all done within the then current scope of science and nothing was to take back. This is once again a debasement for the victims. There was nobody to say anything against that.
FOCUS: How were the conditions in psychiatry after the war was over?
Schneider: It was awful how the mentally ill were kept back then, in the years after the war. People were locked up in big “loony bins” in the countryside. Especially chronically schizophrenic patients lived in these mental institutions for years.
The revolution in psychiatry in Germany emerged later than in other European countries. For one, there were too little psychiatrists due to the enforced emigration, and those who were here continued with the back then normal lock-up psychiatry for the time being. In other countries the social psychiatric movement started earlier. There the chains were opened more quickly.
Source: Jochen Niehaus, “Third Reich: German psychiatry admits to having committed atrocities,” Focus.de, 26 November 2010.

Mass. General disciplines three psychiatrists

Boston Business Journal
by Eric Convey
July 1, 2011

Massachusetts General Hospital on Friday disclosed sanctions against three psychiatrists for violating hospital ethics guidelines by failing to adequately report, internally, seven-figure payments they received from drug companies.

In a statement to colleagues provided by the hospital upon request from the Business Journal, Drs. Joseph Biederman, Thomas Spencer and Timothy Wilens said the disciplinary actions include:

• They must refrain from "all industry-sponsored outside activities" for one year.

• For two years after the ban ends, they must obtain permission from Mass. General and Harvard Medical School before engaging in any industry-sponsored, paid outside activities and then must report back afterward.

• They must undergo certain training.

• They face delays before being considered for "promotion or advancement."

The three doctors came under the political microscope in June 2008 during remarks Sen. Charles Grassley, R-Iowa, made to a committee investigating conflicts of interest involving clinicians.

The three Harvard doctors "are some of the top psychiatrists in the country, and their research is some of the most important in the field," Grassley said, according to an online version of the Congressional record. "They have also taken millions of dollars from the drug companies." The senator complained that Biederman and Wilens took money from drug giant Eli Lilly (NYSE: LLY) at the same time they were being paid by the National Institutes of Health to study an Eli Lilly drug.

Grassley went on to say he had requested conflict-of-interest forms from the hospitals, and they "were a mess."

"My staff had a hard time figuring out which companies the doctors were consulting for and how much money they were making," he said.

When the hospitals asked the doctors to clarify the matter, Grassley continued, "things got interesting."

"Dr. Biederman suddenly admitted to over $1.6 million dollars from the drug companies," Grassley said. "And Dr. Spencer also admitted to over $1 million. Meanwhile, Dr. Wilens also reported over $1.6 million in payments from the drug companies."

"We have learned a great deal from (the in-house investigation)," the doctors wrote in their joint statement released Friday. "And we profoundly hope that our mistakes will benefit our colleagues by bringing clarity and attention to these important issues."

They wrote earlier in the letter: "We always believed that we were complying in good faith with the institutional policies and that our mistakes were honest ones."

In its own statement, the hospital wrote: "A committee at Massachusetts General Hospital that has been looking into conflict-of-interest questions involving three MGH child psychiatrists has completed its review. Appropriate remedial actions have been taken by the hospital to address specific issues."

Psychologist seeks return of license In SJC case, psychologist admits having sex with patient, but says there were mitigating circumstances

Commonwealth Magazine
BY: Colman M Herman
June 22, 2011


A female psychologist is asking the state's Supreme Judicial Court for her license back even though she violated one of the cardinal rules of her profession by having sex with a former patient.

The standard punishment for someone in the medical and related professions who has sex with a patient or former patient is permanent revocation of his or her license. Officials at several of the boards that oversee health professionals said they couldn’t recall an instance where a practitioner who had sex with a patient failed to lose his or her license.

But Brookline psychologist Mary O'Neill says she deserves another chance. She acknowledges beginning a sexual relationship with her patient, Eric MacLeish, just weeks after his therapy sessions ended, yet says her license shouldn’t be permanently revoked because her lapse in judgment was caused by a marriage that had collapsed.

O’Neill petitioned a single justice of the Supreme Judicial Court to review her license revocation by the Board of Registration in Psychology. Subsequently, she and the board jointly asked the full court to hear the case, which it agreed to do. Oral arguments are scheduled for this fall.

O’Neill is arguing that the psychology board “arbitrarily and capriciously” refused to consider the mitigating evidence she presented. Rather than revoking her license, she says the board should have suspended her license for a year and then allowed her to resume work on a probationary basis for a year. She says she would continue to receive personal psychotherapy and have her work supervised by a peer. O’Neill also says she would do 100 hours of community service.

The psychology board’s regulations adopt the code of conduct of the American Psychology Association. The code states that “psychologists do not engage in sexual intimacies with current therapy clients/patients” nor with “former clients for at least two years after cessation of therapy.” Beyond two years, sex between a psychologist and patient is permitted only if the therapist can prove there has been no exploitation. The regulations also say it is not a defense to say the patient consented. The regulations were crafted to prevent psychologists from exploiting the tremendous power they often have over their patients and former patients.

In its April 2010 decision, the psychology board held that O’Neill’s marriage crisis “no doubt exacted a significant emotional toll” on her and that her “marriage crisis can be understood to have ‘clouded’ her judgment.” But the board nonetheless revoked her license, saying her care was the “antithesis of treatment” and her “conduct abrogates a basic tenet of the psychology profession: trust.”

O’Neill’s former patient, Eric MacLeish, is an attorney who is no stranger to sexual abuse. He represented many clients who sued the Catholic Archdiocese of Boston, alleging priests had sexually abused them. He helped pry loose thousands of pages of secret documents on abusive priests from the archdiocese. His lengthy deposition of Cardinal Bernard Law was instrumental in sending the prelate packing. And when the archdiocese settled for $85 million, MacLeish became a wealthy man.

But then his life began to unravel. According to a complaint MacLeish filed with the psychology board and an interview he gave to the Boston Globe in April 2010, all the horrific details he had sat and listened to from his clients triggered a strong emotional reaction in him. He came to realize that he himself had been sexually abused as a child at the hands of a teacher at a boarding school in England and by a scoutmaster associated with the school.

In 2004, MacLeish turned to O’Neill for help. She diagnosed him with having post-traumatic stress disorder and treated him for 10 sessions between August and September 2004. Shortly after treatment ended, they were sleeping together.

Psychology board records contain passionate emails that MacLeish and O’Neill sent to each other after the treatment sessions ended. “You know how incredibly hard it is for me to resist you in every way,” O’Neill wrote in September 2006. “I love you so deeply.” In December 2006, MacLeish emailed O’Neill: “I know this is right, at least for me. . . . I want to be absorbed in your life and with you. It will be very, very healthy. I am just totally in love with you.”

Another email from MacLeish in November 2006 indicates he and O’Neill were discussing the possibility of disciplinary action against O’Neill. “You are exactly right about the prospect of some sort of board inquiry,” he wrote. “You did nothing wrong and you never exploited me,” he wrote.

But MacLeish’s attitude would change when the relationship went sour a year-and-a half later. In October 2007, he sent O’Neill an 11-page letter demanding a written apology from her that “should be sincere and reflect your enormous lapse in judgment as well as your acknowledgment of the damage which you have done.” He also demanded that she receive professional supervision and pay him compensation for the damage she had caused. When he didn’t get what he wanted from her, he filed a lawsuit against O’Neill at the end of 2007, only to withdraw it a year-and-a-half later.

In 2009, MacLeish filed a complaint against O’Neill with the Massachusetts Board of Registration in Psychology, detailing their relationship and his strong feelings for her – feelings that didn’t last. “In retrospect, it was a disaster, filled with pain and manipulation by Dr. O’Neill,” he wrote. “Dr. O’Neill did incredible damage to me, my former wife, and my two kids.”

O’Neill readily admitted that she had become sexually involved with MacLeish within weeks after his therapy sessions with her ended. “It was clearly an extreme violation of ethical code,” according to a transcript of her testimony at the board. “I am really ashamed of my behavior. I am more disappointed in myself than anyone else could be disappointed in me.”

But O’Neill argued that there were mitigating circumstances that the psychology board should consider. She noted that eight months prior to her beginning treatment of MacLeish, her life had also fallen apart. She said her 23-year marriage to another psychologist had ended badly.

O’Neill also said she had no history of discipline and had pursued psychotherapy therapy for herself as well as peer supervision and continuing education on the issue of maintaining proper boundaries with patients.

Dr. Daniel Brown, a forensic psychologist retained by O’Neill, submitted a report to the psychology board in which he said her behavior most likely resulted from “situational factors,” primarily the collapse of her long-term marriage. He said O’Neill could be rehabilitated and there was a very low probability of recidivism.

Brown also was critical in his report of Dr. Stuart Grassian of Newton. Brown said Grassian was the psychiatrist to both O’Neill and MacLeish and a friend of MacLeish. Brown claimed Grassian referred MacLeish to O’Neill and did not discourage her from developing a relationship with MacLeish. “When Dr. O’Neill discussed in advance with Dr. Grassian the possibility of a sexual intimate relationship with MacLeish, she seemed to get ‘permission’ to go ahead with it,” Brown said in his report.

Grassian says he did refer MacLeish to O’Neill but never served as MacLeish’s psychiatrist. He denies saying anything to O’Neill indicating approval of a sexual relationship with MacLeish. “It’s all nonsense,” he said in a telephone interview.

In a psychology board filing, O’Neill’s lawyer said MacLeish was no innocent. “We have a very powerful, experienced, knowing, strong, aggressive, charming, assertive person who . . . wasn’t a little victim who rolled over.” He added: “Mr. MacLeish controlled the details of this relationship as he had with the numerous other extramarital relationships that he had admitted to enjoying during his then marriage.”

Neither MacLeish nor O’Neill’s attorney responded to requests for comment.

Attorneys familiar with case law on license revocations said it was unlikely the Supreme Judicial Court would return O’Neill’s license to her. "I have empathy for Dr. O'Neill," said Linda Jorgenson, a Massachusetts attorney who has represented hundreds of people who have claimed their therapists abused them sexually. "But her first obligation is to her patients. What she did to Mr. MacLeish was, plain and simple, wrong, and the revocation of her license was an appropriate sanction."

Thomas Gutheil, professor of psychiatry at Harvard Medical School and co-author of Preventing Boundary Violations in Clinical Practice, said there are always mitigating factors helping to explain why therapists have sex with their patients. “But they are never a justification for behavior clearly recognized as wrong,” he said.

Clinical psychologist Gary Schoener, who has written extensively about the sexual misconduct of therapists, said courts rarely overrule licensing boards in such cases. “The reason for this is that they are supposed to have more expertise in the issue of how to protect the public, and these cases involve a lot of professional opinion in a given field,” he said.

Janet Wohlberg, a victim advocate and herself a victim of sexual abuse by a psychiatrist, has a suggestion for the SJC justices. “They should ask themselves whether they would send a member of their family to Dr. O’Neill – their child, their spouse, their parents.”