Of Medical Giants, Accolades and Feet of Clay

By LAWRENCE K. ALTMAN, M.D.
The New York Times
Published: April 1, 2013

Medicine honors its heroes in many ways. But sometimes high accolades can turn out to be highly embarrassing.

Consider the annual award for lifetime achievement in preventing and controlling sexual infections, given since 1972 by the American Sexually Transmitted Diseases Association. The prize is named for an authentic giant of medicine: Dr. Thomas Parran Jr., the nation’s sixth surgeon general (from 1936 to 1948), who used what was then a supremely powerful position to lift American public health to the front ranks.

At a time when “venereal diseases” were spoken of in whispers, Dr. Parran influenced Congress to finance rapid-treatment centers to control and prevent syphilis, gonorrhea and chancroid.

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The debate over the Parran Award throws a spotlight on the issue of changing standards in medicine. What are scientists to do when they name their most prestigious award for an icon linked years later to unethical research?

The two medical scandals revolved around experiments that are now universally regarded as shocking. Dr. Parran did not perform either study. Though national experts approved them both, he presided over them, strongly supported them and followed their progress in medical journals.

One, the Tuskegee study, observed the course of untreated syphilis among hundreds of men who were infected naturally in Alabama. The study began in 1932, and it was not halted by the United States Public Health Service until 1972, after a whistle-blower complained that infected patients in the study were not given penicillin, the standard therapy after World War II.  Some participants died of the disease, some of their sexual partners contracted it, and some children were born infected.

The entire story is here.

Large HMO Cited in Mental Health Care Cover-up

Nancy A. Melville
Medscape Medical News
Apr 03, 2013

California's Department of Managed Health Care (DMHC) has cited Kaiser Permanente for using a deceptive dual record-keeping system to cover up violations of the state's "timely access" law, which restricts the amount of time mental health patients should have to wait for an appointment, as well as for other violations.

In a report filed last month, the DMHC concludes that many Kaiser mental health patients faced extensive waiting periods for appointments, well beyond the 10 days for a regular appointment that the law requires.

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Clinician Whistle-blowers

The violations were discovered through a standard survey or evaluation process that the DMHC uses to review compliance by all California health plans.

After the review was underway, complaints regarding timely access violations were brought forward by a group of Kaiser Permanente's own mental health clinicians, who were represented by the National Union of Healthcare Workers (NUHW). Those complaints were considered and incorporated in the evaluation, Rouillard said.

Among the psychologists lodging complaints was Andris Skuja, PhD, who said the violations had been observed for years before the clinicians referred their concerns to the DMHC.

"Over a number of years, we tried many internal mechanisms with Kaiser to address some mounting concerns we had about the adequacy of treatment," Dr. Skuja told Medscape Medical News.

The entire story is here.

A previous news story about this topic can be found here.

Kaiser Permanente cited for EHR mental health violations

By Jennifer Bresnick
EHR Intelligence
Originally published on March 20, 2013

Kaiser Permanente, the largest healthcare provider in California, has been cited by the California Department of Managed Healthcare (DMHC) for keeping two sets of patient records: an official EHR that it showed to state inspectors, and a parallel paper record that hid violations of the state’s “timely access” law that mandates shorter wait times for mental healthcare than Kaiser was able to provide.  The inaccuracies involved in the HMO’s dual record keeping system meant that mental health patients may have waited weeks longer than the law stipulates for appointments, resulting in illegal denials of access to care for schizophrenia, autism, depression and suicidal ideation, among other serious conditions.

The problem stems from Kaiser’s double appointment keeping procedures.  While there is an electronic version – the version that gets reported to government officials – Kaiser also used paper lists in some facilities, rendering its electronic appointment wait time calculators useless.

The entire story is here.

Thanks to Ed Zuckerman for this story.

The Shredder Ate My Culture Report: Five Questions the Barclays Board Should Have Asked

By Donna Boehme
Corporate Compliance Insights
Originally published on February 13, 2013


It’s been a terrible, horrible, no good, very bad few weeks for Barclays.   Despite tough talk last month by new CEO Antony Jenkins about “Five New Values” (inviting any of its 140,000 employees who don’t want to sign up to head for the exits), the bad news just keeps on coming for the embattled firm.  And the latest round involves a shredder.

Last week’s headlines of “Shreddergate” and “Qatargate” spelled out the bank’s latest troubles.  In the former, Andrew Tinney, the chief operating officer of the bank’s high-end investment division, commissioned a “workplace culture report” from an outside consultancy, but was so horrified by its contents that he shredded the report on the spot at his Surrey estate and then, according to media reports,  “denied all knowledge of it ever having existed.” Neat trick, until an anonymous internal whistleblower emailed Jenkins a hint about the mysterious culture report.   Add to this the latest revelations about a Qatari cash injection at the height of the financial crisis that may have been funded by the bank itself, which means the bank may have lied to UK regulators.

Mind you, this is after an annus horribilis in which Barclays was hit by a half a billion dollar fine for its part in manipulating LIBOR, lost its Chairman, CEO and COO in quick succession, and saw its credit rating lowered by Moody’s from “stable” to “negative.”  The scandal ripples from that debacle continues, as the firm has just announced the exit of two more top execs: its finance chief and general counsel.

The entire article is here.

Amgen Agrees to Pay $762 Million for Marketing Anemia Drug for Off-Label Use

By ANDREW POLLACK and MOSI SECRET
The New York Times
Published: December 18, 2012

The biotechnology giant Amgen marketed its anemia drug Aranesp for unapproved uses even after the Food and Drug Administration explicitly ruled them out, federal prosecutors said on Tuesday.

The federal charges were made public as Amgen pleaded guilty to illegally marketing the drug and agreed to pay $762 million in criminal penalties and settlements of whistle-blower lawsuits.

Amgen was “pursuing profits at the risk of patient safety,” Marshall L. Miller, acting United States attorneyin Brooklyn, said in a telephone news briefing on Tuesday.

David J. Scott, Amgen’s general counsel, entered the guilty plea at the United States District Court in Brooklyn to a single misdemeanor count of misbranding the drug, Aranesp, meaning selling it for uses not approved by the F.D.A.

Amgen agreed to pay $136 million in criminal fines and forfeit $14 million, with about $612 million going to settle civil litigation.

The entire article is here.

Justice Dept. recovers record $5 billion under False Claims Act

By Peter Finn
The Washington Post
Originally published: December 4, 2012


The Justice Department’s civil division recovered a record $5 billion in the past fiscal year from companies that defrauded taxpayers, with much of the abuse occurring in the health-care and mortgage industries.

The department pursued settlements and judgments under the False Claims Act, which Acting Associate Attorney General Tony West described Tuesday as “quite simply, the most powerful tool we have to deter and redress fraud.”

“Vigorous enforcement of the act allows us to protect not only taxpayer dollars but also the integrity of important government programs on which so many Americans rely,” West said.

The amount of money recovered in 2012 is up from $3.2 billion last year, and two-thirds of it was secured through the act’s whistleblower provisions.

“Many of these cases would not be possible without the whistleblowers . . . who have come forward to report fraud, often at great personal risk,” said Stuart Delery, the principal deputy assistant attorney general for the civil division.

The entire story is here.

Official Rescinds Punishment of Psychologist on Reservation

By Timothy Williams
The New York Times
Originally published August 2, 2012

A government psychologist who was officially reprimanded for alerting his superiors to widespread child abuse on a North Dakota Indian reservation has had his punishment rescinded, the Department of Health and Human Services announced Thursday.

The psychologist, Michael R. Tilus, director of behavioral health at the Spirit Lake Health Center on the Spirit Lake Reservation, said he had been acting as a whistle-blower when he e-mailed letters to senior federal health officials, law enforcement agents and North Dakota’s United States senators about what he described as an “epidemic” of child abuse at Spirit Lake and the lack of effort by the tribe’s leaders to address the problem.

The entire article is here.

The original story on this blog about Michael R. Tilus is here.

Psychologist Who Wrote of Abuse Is Punished

By Timothy Williams
The New York Times
Originally published July 30, 2012

A federal health services psychologist who told superiors that an American Indian tribe was ignoring widespread child abuse on a North Dakota reservation has been reprimanded and reassigned, according to federal officials and documents.

The psychologist, Michael R. Tilus, director of behavioral health at the Spirit Lake Health Center on the Spirit Lake Indian reservation, describes himself as a whistle-blower. He wrote in an e-mail to state and federal health officials this spring about an “epidemic” of child abuse on Spirit Lake, which is in a remote area of northeastern North Dakota.

Among the recipients were officials with the Department of Health and Human Services and the Indian Health Service, which oversee most health care on Spirit Lake.  

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Dr. Tilus wrote that instead of being punished, he deserved whistle-blower protection under the Food and Drug Administration Safety and Innovation Act of 2012, which was signed into law by President Obama this month. That law extends military whistle-blower safeguards to federal Public Health Service officers.

The entire story is here.

Alzheimer's research fraud case set for trial

By Toni Clarke
Reuters Health News
Last updated May 11, 2012

Two Harvard teaching hospitals and a prominent Alzheimer's disease researcher accused of using falsified data to obtain a government research grant are set to stand trial after a federal appeals court said this week that a lower court erred when it dismissed the case.

The lawsuit accuses Marilyn Albert, a former professor of psychiatry at Harvard Medical School, and Massachusetts General Hospital (MGH), where she was conducting research, of submitting a grant application based on manipulated data.

The data showed results from a trial were scientifically significant when in fact they were not, according to the lawsuit.

Brigham and Women's Hospital, which collaborated on the research, is also a defendant in the case. The lawsuit was brought in 2006 under the False Claims Act, a 150-year-old federal law designed to recover government funds appropriated through fraud.

This is the first time a lawsuit dealing with alleged scientific fraud has been allowed to progress to trial under the False Claims Act, according to Michael Kohn, a lawyer with Kohn, Kohn & Colapinto in Washington, D.C.

The entire story is here.

2 Former Kaplan Employees Settle Lawsuit and Withdraw Whistle-Blower Case

By Goldie Blumenstyk
The Chronicle of Higher Education
Originally published on April 11, 2012

Two former employees of a Kaplan-owned college in Pennsylvania who alleged in a 2006 federal whistle-blower lawsuit that the company had falsified graduation and job-placement rates and had paid illegal bonuses to student recruiters have withdrawn their suit. The two also reached a settlement with Kaplan on an employment-discrimination claim alleging that the company had fired them in retaliation for saying they would report wrongdoing.

The terms of the settlement are confidential.

The entire story is here.

WellCare Health Plans whistle-blower to receive about $21 million

By Jeff Harrington

Tampa Bay Times

Originally published on April 4, 2012

Whistle-blower Sean Hellein will receive nearly $21 million for triggering a successful federal inquiry into Medicare and Medicaid fraud at his former Tampa employer, WellCare Health Plans.

Hellein in late February withdrew his objections to a pending $137.5 million civil settlement with WellCare. But the size of his payout was unclear until Tuesday, when U.S. Attorney Robert O'Neill announced the settlement of all four lawsuits initiated by whistle-blowers.

The entire story is here.

The Crazy Things That One Whistleblower Says Are Happening At JP Morgan Will Blow Your Mind

By Michael Snyder

Hawaii News Daily

Originally published March 16, 2012

Rampant silver manipulation? 

Rampant gold manipulation? 

Rampant LIBOR manipulation? 

Hiding MF Global client assets? 

These are all happening at JP Morgan according to an open letter reportedly written by an anonymous employee of the firm.  The whistleblower also warns of a "cascading credit event being triggered" by derivatives related to Greek government debt. 

Unlike Greg Smith at Goldman Sachs, this whistleblower has chosen to remain anonymous for now.  According to the letter, the whistleblower is still an employee of JP Morgan and has not resigned.  But that does make it much more difficult to confirm what he is saying.  With Greg Smith, we know exactly who he is and what he was doing at Goldman.  As far as this anonymous whistleblower is concerned, all we have is this letter.  So we must take it with a grain of salt.  However, the information in this letter does agree with what whistleblowers such as Andrew Maguire have said in the past about silver manipulation by JP Morgan.  And this letter does mention Greg Smith's resignation from Goldman, so we know that it must have been written in the past few days.  Hopefully this letter will cause authorities to take a much closer look at the crazy things that are going on over at JP Morgan and the other big Wall Street banks.

This anonymous letter was addressed to the CFTC, but unfortunately it looks like the CFTC has already chosen to ignore it.

The original letter from this anonymous whistleblower has already been taken down from the CFTC website.  When you go there now, all you get is this message....

"The Comment Cannot Be Found. Please Return to the Previous Page and Try Again."

Fortunately, there are many in the alternative media that copied this entire letter from the CFTC website.

The entire story is here.

Texas Physician Pleads Guilty in Whistle-Blowing Nurses Case

By Robert Lowes
Medscape News Today

Rolando Arafiles Jr, MD, today pled guilty to criminal charges in a state court in Winkler County, Texas, for retaliating against 2 nurses who had anonymously reported him in 2009 to the Texas Medical Board (TMB) over the quality of his patient care.



Anne Mitchell, RN and Vickilyn Galle RN



The case set off a national conversation on the protection afforded healthcare whistle-blowers.

The 2 nurses, Anne Mitchell, RN, and Vickilyn Galle, RN, had worked with Dr. Arafiles at Winkler County Memorial Hospital in Kermit, Texas. Once they were identified as the whistle-blowers by a county investigation that Dr. Arafiles instigated, the nurses were charged with misuse of official information, which is a third-degree felony, and fired. The charge against Galle was dropped, and a jury last year quickly found Mitchell not guilty.

Today, the 59-year-old Dr. Arafiles pled guilty to 1 count each of misuse of official information and retaliation, which is also a third-degree felony. He was sentenced to 60 days in jail and fined $5000. A press release issued by the office of Texas Attorney General Greg Abbott stated that with today's plea, Dr. Arafiles admits to urging former Winkler County Sheriff Robert Roberts Jr and former Winkler County Attorney Scott Tidwell to strike back against the nurses.

On November 4, he signed an order with the TMB to voluntarily surrender his state medical license effective November 11. He faced the possibility of the board revoking his license on account of a felony conviction.

The entire story is here.

Should you blow the whistle?

What to do when you suspect your adviser or research supervisor of ethical misconduct.

By Cassandra Willyard

The Monitor on Psychology

After graduating with a master’s in counseling, “Jackie Frank” (not her real name) decided to get some research experience before applying to a PhD program. She took a position at a small medical center where a researcher had a grant to study post-traumatic stress disorder and substance abuse. As part of the job, Frank interviewed study volunteers to assess the severity of their condition — and that’s when she noticed something fishy was going on.

“Our supervisor framed leading questions and expected you to do that as well,” Frank says. The researchers, she believes, were trying to manipulate the study results “to make a bolder, statistically significant statement.”

Frank later noticed that some of data had been changed. “At that point, I knew we didn’t have the same ethical values,” she says.

Frank debated whether to “suck it up,” but ultimately decided to leave before her funding ran out. In her exit interview, she brought up her concerns and handed in a formal letter detailing her observations. Not long after, she heard that the lead researcher was under investigation for possible misconduct.

Nearly every graduate student faces ethical uncertainties, says Melissa Anderson, PhD, a professor of higher education at the University of Minnesota in Minneapolis who studies research integrity. But these quandaries become even more complicated when you suspect that your superior is involved in ethical misconduct.

“Graduate students, like all other researchers, are working at the frontier of knowledge,” she says. “And with every new thing, there’s the potential for new ethical complications.” The line between “cleaning up” and “cherry picking” data can be fuzzy, for example. And students may not be privy to all the nuances of a study’s protocol.

Even if ethical misconduct is clear, whistle-blowing may not always be the best option for you, says Michael Zigmond, PhD, a neurology professor at the University of Pittsburgh and associate director of an ethics workshop for graduate students. If you’re a fourth-year student and your adviser adds the head of the department to your paper even though he didn’t do any work, bringing it to the authorities’ attention may not be worth the potential damage to your career. On the other hand, if you’re working for a professor in another department and you witness sketchy research practices, quitting quietly and sharing your concerns in an exit interview — as Frank did — might be a good way to go.

Here’s some tried-and-true advice on how to navigate these and other ethical quagmires:

• Review the evidence. Avoid jumping to conclusions, Anderson says. You may not know the whole story. Reflect on your communications with the person you suspect of wrongdoing. What led you to suspect something isn’t quite right? Is there evidence to support what your gut is telling you?

If you don’t know what constitutes misconduct, consult your university’s guidelines or the U.S. Office of Research Integrity’s handbook on responsible conduct of research. Every university that receives federal research funding is obligated to adopt the federal definition of scientific misconduct — fabrication, falsification or plagiarism — and some institutions may have even stricter definitions.

Then write notes about any ethical violations you suspect, suggests Anderson. Be sure to jot down the details of every conversation: What was said, who was present, where it occurred, and the date and time. Save your emails, both the ones you send and the ones you receive. Keeping track of what you see can help you form a conclusion and provides invaluable documentation if you decide to report the situation. “Good recordkeeping throughout a research collaboration is important in any case,” she says. “But it becomes really important when something bad is going on.”

The rest of the story is here.

N.Y. Still Pursues Case Against Whistle-Blower

By Danny Hakim
The New York Times

The Cuomo administration is continuing to pursue a two-year-old disciplinary case against Jeffrey Monsour, a state employee at the Office for People With Developmental Disabilities who has been an outspoken critic of the agency’s management.

Mr. Monsour, 50, a direct-care worker, is accused of getting into an argument with a co-worker in front of a resident in 2009. The state is seeking a four-week suspension, a penalty that exceeds those imposed on many employees who committed acts of abuse or neglect against developmentally disabled people.

Mr. Monsour has long been a gadfly within the office, which runs more than 1,000 group homes and institutions. Over the years, he has filed many Freedom of Information requests examining its practices, annoying agency officials, and he sees the case being brought against him as their latest attempt at retribution.

The case highlights the agency’s haphazard approach to discipline.

Mr. Monsour was written about by The New York Times in March; that article told of a state worker who, while being investigated by the police in a case of sexual assault against a severely disabled resident, returned to his job without penalty, despite witness testimony and DNA evidence implicating the employee. That worker was eventually convicted of endangering an incompetent person, a charge stemming from the assault case, and was jailed. Another worker described in the article racked up multiple offenses, including twice punching residents in the face, before losing his job.

This year, Gov. Andrew M. Cuomo forced out the agency’s commissioner, installing Courtney Burke, a policy expert, in the position, and he has asked Clarence J. Sundram, a former regulator, to lead a broad review of the agency’s practices. Seeking to add predictability to the disciplinary system, the administration recently negotiated a plan with the Civil Service Employees Association to create a matrix of punishments for various offenses.

But it has continued to pursue the case against Mr. Monsour.

Last month, after prodding by The Times and Mr. Monsour’s lawyer, the administration took the unusual step of turning over nearly 200 pages of transcripts from Mr. Monsour’s arbitration proceedings, offering a rare window into a continuing disciplinary case involving a state employee.

The rest of the story can be found here.

Harvard Psychologist Resigns

The Chronicle of Higher Education
by Tom Bartlett

Marc Hauser, PhD

Marc D. Hauser, the Harvard psychologist found responsible for eight counts of scientific misconduct by the university, has resigned, ending speculation about whether the embattled professor would return to campus this fall.

In a letter dated July 7, Mr. Hauser wrote to Michael D. Smith, Harvard's dean of the Faculty of Arts and Sciences, that he was resigning effective August 1 because he had "some exciting opportunities in the private sector" and that he had been involved in some "extremely interesting and rewarding work focusing on the educational needs of at-risk teenagers."

The letter states that he may return to teaching and research "in the years to come." It does not mention the scandal that damaged his once-stellar reputation and stunned his colleagues in the field.

Last August, The Boston Globe reported that a university investigation had found Mr. Hauser guilty of misconduct, though the nature of that misconduct remained murky. The picture became somewhat clearer after Mr. Smith, the Harvard dean, sent a letter to faculty members saying that Mr. Hauser was "solely responsible" for eight instances of wrongdoing involving three published and five unpublished studies.

An internal document provided last August to The Chronicle by a former research assistant in Mr. Hauser's laboratory revealed how members of the lab believed Mr. Hauser was reporting faulty data and included e-mails demonstrating how he had pushed back when they had brought problems to his attention. Several lab members alerted the university's ombudsman, setting in motion an investigation that would lead to the seizure of computers and documents from Mr. Hauser's laboratory in the fall of 2007.

Read the entire article here.