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."

Nursing Home Drug Use Puts Many at Risk, Antipsychotics given to some with dementia

The Boston Globe
By Kay Lazar, Globe Staff
March 8, 2010

Nearly 2,500 nursing home residents in Massachusetts were given powerful antipsychotic drugs last year that were not intended or recommended for their medical condition, a practice that is more common here than in most other states, according to a Globe analysis of federal data.

Data collected by the federal Centers for Medicare and Medicaid Services show that 28 percent of Massachusetts nursing home residents were given antipsychotics in 2009. Of that group, 22 percent - or 2,483 - did not have a medical condition that calls for such treatment.

That rate was the 12th highest in the nation, according to the federal data.

The use of such drugs is especially worrisome in nursing homes because a substantial number of residents suffer from dementia, a condition that puts them at greater risk of death when given antipsychotic medications.

The drugs, also known as “‘psychotropics,’’ were developed to treat people with severe mental illnesses such as schizophrenia, not dementia, which is the progressive loss of memory or other intellectual function than can result from aging or Alzheimer’s disease.

Twice in the past five years, federal regulators have issued nationwide alerts about troubling and sometimes fatal side effects when antipsychotics are taken by people with dementia, including increased confusion, sedation, and weight gain.

Scott Plumb, senior vice president of the Massachusetts Senior Care Association, the trade group representing the state’s 440 nursing homes, said Massachusetts’ consistent ranking as one of the heaviest users of psychotropic drugs indicates much more training is needed in nursing homes.

“We recognize the number is too high,’’ Plumb said, “and we are working to try to bring it down.’’

As the nation ages - up to 14 million baby boomers are expected to develop Alzheimer’s disease or a similar dementia - the drugging of such vulnerable patients takes on increasing urgency. While there has been much focus on the increasing use of antipsychotic drugs among children - highlighted by the recent overdose death of 4-year-old Rebecca Riley - much less attention has been paid to the similar problem among seniors.

“Way too many patients in nursing homes are treated with antipsychotics purely to sedate them or to control behaviors that are difficult for the staff,’’ said Robert A. Stern, an Alzheimer’s specialist and brain researcher at Boston University School of Medicine.

“To the defense of nursing homes and nursing home staff,’’ Stern said, “they are indeed understaffed, they are indeed under-trained, and it takes an awful lot of well-trained people to manage the difficult behaviors that can be exhibited by people with dementia.’’

While there is no barometer for what is considered an appropriate amount of antipsychotic use in nursing homes - and there is no law governing the matter - specialists in caring for the elderly note that the use of antipsychotics is much lower in some homes than others, and in some states than others.

They also point to the federal government’s recent legal action against the largest provider of drugs to nursing homes in the United States. The company, Omnicare, agreed in November to pay $98 million to settle charges that it took kickbacks from Johnson & Johnson to recommend the drug maker’s products, including the antipsychotic Risperdal. The government said Omnicare persuaded physicians to prescribe the medication to dementia patients with behavioral problems. A government suit against J&J is pending.

Specialists say antipsychotics can improve the quality of life for some dementia patients who suffer from extreme agitation and sleeplessness, common symptoms of Alzheimer’s. But too often nursing homes don’t regularly reevaluate patients’ medications to determine whether the antipsychotics are, in fact, effective and whether the dose can be lowered or eliminated, said psychologist Paul Raia, vice president of clinical services for the Massachusetts and New Hampshire Alzheimer’s Association.

Raia helps train nursing home staff in behavior management techniques that can ease agitation and the need for the drugs - skills and training that, specialists say, are often lacking in nursing homes in Massachusetts and across the country. In these homes, he said, as many as 80 percent of the residents are on antipsychotic drugs.

“And then I walk into a good place, one with training, and see 2 or 3 percent on these medications,’’ he said.

A nursing home’s track record for antipsychotic use often is a good predictor for future patients, according to new research from the University of Massachusetts Medical School. The scientists analyzed data from 1,257 nursing homes nationwide and found that patients newly admitted to facilities with some of the highest rates for prescribing antipsychotics are 37 percent more likely to receive the drugs than patients entering homes with the lowest prescribing rates.

Nicki Solomon of Norwood has seen those highs and lows. In 2007, she placed her mother, Corinne, in a nursing home. Although the retired surgical nurse suffered from dementia, she was still able to feed herself and converse clearly, but she had lost her short-term memory, was sometimes agitated and anxious, and would wander off.

Solomon said the nursing home, High Gate Manor in Dedham, asked her permission to prescribe her mother an antipsychotic but didn’t explain the potential side effects. Within weeks, Solomon said, her mother was transformed into someone she didn’t know.

“My mother was out of it all the time. She was asleep and noncommunicative,’’ Solomon said. “She was smothered.’’

She had been given Seroquel, Solomon said, one of the drugs that federal regulators months later would specifically warn against for dementia patients.

High Gate, citing patient confidentiality laws, declined to comment on Solomon’s care.

In June 2008, Solomon transferred her mother to a Needham nursing home that specializes in using alternatives to medication in caring for dementia patients. Her mother rebounded, she said, living another 15 months before her death last November.

Alice Bonner, the state’s top nursing home regulator as director of the Bureau of Health Care Safety and Quality, said “culture change,’’ including a growing consumer movement that focuses on more closely involving families and patients in care decisions, can lower the use of psychotropic drugs.

“We can do better, and use fewer drugs, and do more with behavioral interventions by changing the way we deliver care in nursing homes,’’ she said. Her agency is developing a brochure for nursing homes to give new residents and their families, encouraging them to ask y about the medications prescribed.

For Sharlene Hemp, a North Andover resident who says her father died from side effects of psychotropic drugs just 34 days after entering a nursing home, the answer is legislation. Her father had Alzheimer’s, but she said the family was never told about the medications nor of the potential lethal side effects, until after his death in 2001.

Hemp persuaded her state senator, Steven A. Baddour, to file legislation that would require all Massachusetts nursing homes and their prescribing physicians to obtain written permission from a patient’s health care proxy, which is often a family member, and a court appointed guardian before using antipsychotic medications. A public hearing was held on the bill in January, and it remains in committee.

“When you put a loved one in a nursing home, you are putting your trust in the nursing home and the doctor,’’ Hemp said. “But you don’t know when they go in that they are given all these drugs, and especially dementia patients, because they can’t tell you what they are given.’’

Kay Lazar can be reached at klazar@globe.com.
© Copyright 2010 The New York Times Company

Bipolar diagnosis jumps in young children: study

Ros Krasny
(Reuters)
BOSTON

Fri Jan 15, 2010

BOSTON (Reuters) - The number of children aged 2 to 5 who have been diagnosed with bipolar disorder and prescribed powerful antipsychotic drugs has doubled over the past decade, according to research released on Friday.

Health

The research suggests that while it is still rare to prescribe powerful psychiatric drugs to 2-year-olds, the practice is becoming more frequent.

The data, compiled from 2000 to 2007, and published in the Journal of the American Academy of Child & Adolescent Psychiatry, could inform testimony at the upcoming Boston-area murder trials of the parents of 4-year-old Rebecca Riley. The girl died of an overdose of mood-stabilizing medication in 2006.

A Boston child psychiatrist, Kayoko Kifuji, diagnosed Riley with bipolar disorder and attention deficit hyperactivity disorder when she was 30 months old, and placed her on several powerful drugs: Depakote, an antiseizure medication also used for bipolar disorder, and clonidine, a blood pressure medication.

Kifuji's testimony may be crucial to the fate of Michael and Carolyn Riley, who face first-degree murder charges. A grand jury and a review by the state's medical licensing board cleared the doctor of wrongdoing.

Prosecutors claim the Rileys deliberately overmedicated their daughter to subdue her. The couple say they were following Kifuji's instructions and their daughter died of pneumonia.

The case has shone the spotlight again on a debate within the psychiatric profession about whether bipolar disorder can be diagnosed in very young children and whether it is wise to prescribe powerful medications.

BIPOLAR TODDLERS?

Bipolar disorder, characterized by severe mood swings, was once thought to emerge only during adolescence or later. But Dr. Joseph Biederman, a child psychiatrist at Harvard University, transformed views on the subject by arguing that children could have the disorder at extremely young ages.

He is credited with spearheading a more than 40-fold increase in the number of children diagnosed with bipolar disorder over the past decade.

Biederman was accused in 2008 by Republican U.S. Senator Charles Grassley of failing to fully disclose payments by drug companies, including some that produced medication for bipolar disorder. Biederman declined to be interviewed about the latest study.

"The psychiatric diagnosis of very young children is anything but an exact science," said Harry Tracy, a psychologist and publisher of NeuroInvestment, a monthly publication specializing in central nervous system disorders.

"Such disparate causes as ADHD, depression, bipolar disorder, sexual abuse, and family dysfunction can produce very similar symptoms in a toddler."

The report's author, Mark Olfson, professor of clinical psychiatry at Columbia University, said about 1.5 percent of all privately insured children between the ages of 2 and 5, or one in 70 children, received some sort of psychotropic drug -- whether an antipsychotic, a mood stabilizer, a stimulant or an antidepressant -- in 2007.

If a child is diagnosed with bipolar disorder between the ages of 2 and 5, about half are prescribed an antipsychotic, such as Eli Lilly & Co's Zyprexa, AstraZeneca Plc's Seroquel, and Johnson & Johnson's Risperdal. They are prescribed to about one in 3,000 2-year-olds, according to his report.

"There might be a role for these drugs but only after you've tried other interventions, with the parents, or with the parents and child together, but that is not happening when you examine the billing records," Olfson said.

(Additional reporting by Toni Clarke; Editing by Peter Cooney)

Pfizer's huge fine: A disturbing trend Do the increasing penalties against drug companies really cure the problem?

Salon.com
By Vincent Rossmeier
Sep. 03, 2009 |

$2.3 billion: That's the price pharmaceutical giant Pfizer agreed to pay in a settlement Wednesday over its misleading marketing for the painkiller Bextra, the antipsychotic Geodon, the antibiotic Zyvox, and another painkiller, Lyrica. It's a record settlement that included the highest fine charged in U.S. history and came as the result of a lengthy Department of Justice investigation into healthcare fraud.

Though Pfizer voluntarily withdrew Bextra from the market in 2005, in the settlement, the company concedes that they had pushed doctors to prescribe unsafe doses of the drug prior to that point. The drug was approved by the FDA in 2001 for the treatment of pain associated with menstrual cramps and arthritis, but Pfizer encouraged its sales representatives to entice doctors to prescribe the drug in doses higher than those approved by the FDA. The escalated doses increased the chances that users of the drug would suffer a heart attack or a stroke. Pfizer also marketed Zyvox as a treatment for specific kinds of bacteria on which the drug had no effect.

A former Pfizer sales representative, John Kopchinski, whose questioning of the company's marketing tactics helped lead to the investigation, will receive over $51 million from the settlement. Kopchinski lost his job as a result of blowing the whistle on Pfizer's illegal schemes. Pfizer will have to pay settlements in 42 states and the District of Columbia.

However, the hefty cost will probably barely affect Pfizer's overall profit margins: The company purchased rival Wyeth in January for $68 billion and had revenues of over $48 billion last year. As the New York Times pointed out, "While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales." This is the fourth time Pfizer has reached a settlement over fraudulent marketing since 2002.

In the wake of Pfizer's settlement, here's a look at some of the larger Big Pharma settlements in recent history:

* Zyprexa, 2009 -- Eli Lilly was accused of selling its top-selling drug Zyprexa widely -- even to those people without bipolar disorder or schizophrenia for which the drug was supposed to be used. The drug can cause severe weight gain, as well as increasing the risk of a patient developing diabetes. In January, Eli Lilly reached a settlement with the government for $1.4 billion.
* OxyContin, 2007 -- Introduced in 1996 by Purdue Pharma, OxyContin was advertised as a softer, gentler painkiller. However, the drug is actually highly addictive, acting like heroin if taken incorrectly. OxyContin has become a scourge to communities across the U.S. and has also led to numerous overdose deaths. Perhaps the most notorious abuser of OxyContin was conservative radio talk show host Rush Limbaugh. In 2007, Purdue Pharma agreed to cough up $634.5 million in fines for its false claims about the drug.
* Vioxx, 2007 -- When 47,000 people are involved in a lawsuit against you, you know you have a problem. Thus, Merck, the maker of the painkiller Vioxx, reached a $4.85 billion settlement in 2007 to get rid of all the pending cases brought against it due to Vioxx's negative side effects. Vioxx was found to double the risk of heart attacks and strokes and thus Merck pulled the pill from pharmacies in 2004.
* Serostim, 2005 -- Serono, a Swiss technology company, had to pay $700 million in 2005 as a result of its fraudulent marketing for the AIDS drug Serostim. Serono developed a test that inflated the seriousness of the symptoms of a patient afflicted with AIDS and also sponsored junkets for doctors in order to get them to prescribe the drug.
* Neurontin, 2004 -- Pfizer reached a settlement of $430 million to end criminal and civil charges about its practice of paying doctors to prescribe Neurontin, a drug for epilepsy, to patients with bipolar disorder, for which it was not approved.
* Cipro, 2003 -- Bayer reached a $257 million settlement in 2003, the largest Medicaid fraud settlement at that time, after being charged by federal investigators with overcharging for the antibiotic Cipro. Bayer, however, didn't act alone: It received advice on how to go about the scheme from healthcare giant Kaiser Permanente.
* Paxil and Flonase, 2003 -- GlaxoSmithKline allegedly didn't want to miss out on all the fun and profits Bayer was having in overcharging for Cipro. It was accused of running a scheme with Kaiser Permanente to bilk Medicaid for the antidepressant Paxil and the allergy spray medication Flonase. GlaxoSmithKline paid $87.6 million in 2003 to settle the case.
* Lupron, 2001 -- TAP Pharmaceuticals Inc. came up with a clever way to get doctors to use its prostate cancer drug, Lupron, instead of those of rival drug companies: namely, pay them. TAP offered one doctor $25,000 to go back to prescribing Lupron after he'd switched to a competitor's drug. But the doctor alerted authorities, who conducted a massive sting resulting in TAP dishing out a $875 million settlement in 2001.
* Fen-Phen, 1999 -- Billed as a miracle diet drug by the drug company American Home Products Corp. (AHP), Fen-Phen was just as good at promoting heart valve disease as it was at helping people shed excess pounds. AHP removed Fen-Phen in 1997 after a damaging report showed that those who took the drug for more than two years increased their risk of developing heart valve disease by 17 percent. Though AHP agreed to pay $3.75 billion to the users of the drug, it did not have to admit to any wrongful actions in its marketing of Fen-Phen.

Doc Who Urged Antipsychotics for 3-Year-Olds Funded by J&J, AZ and Shire

BNET
By Jim Edwards | Aug 28, 2009

A doctor who wrote in an academic journal that preschoolers may suffer from depression and could be good candidates for atypical antipsychotics received funding from three drug companies that make mental health medicines.

Dr. Joan Luby, a professor of child psychiatry at the Washington University School of Medicine in St. Louis, wrote that children as young as three years old may suffer from bipolar disorder, and that there are “promising findings for the use of atypical antipsychotic agents and mood stabilizers, both singly and in combination” in the very young. Atypical antipsychotics are not FDA-approved for such use.

Her article, in a 2009 journal titled Child and Adolescent Psychiatric Clinics of North America, does not disclose that in the past Luby’s work has been funded by Janssen (the unit of Johnson & Johnson that markets Risperdal), or that she has given talks sponsored by AstraZeneca (maker of Seroquel), and has been a consultant for Shire (maker of Adderall XR and Vyvanse).

Luby (pictured) disclosed her relationships with drug companies in a 2006 article in the Journal of the American Academy of Child & Adolescent Psychiatry, which was also about depression in preschoolers. Her disclosure said:

Disclosure: Dr. Luby has received grant/research support from Janssen, has given occasional talks sponsored by AstraZeneca, and has served as a consultant for Shire Pharmaceuticals.

Luby did not return an email or two phone calls requesting comment. It is not clear whether academic journal rules at the time required her disclosures. AZ said:

AstraZeneca records show that Dr. Luby participated in our speakers program from 2003-2004. It is AstraZeneca policy to compensate speakers according to the fair market value of their services.

After checking its records, Shire said it paid $2,000 to Luby in 2004, plus a $19 in travel expenses.* J&J did not respond to a message requesting comment.

Luby is not the only academic researcher whose disclosure of Big Pharma funding has been spotty. Sen. Chuck Grassley, R-Iowa, is pushing for transparency legislation that would force all university researchers to disclose their ties to drug companies.

A selection of Luby’s published papers on childhood depression shows that while in 2006 she did disclose her payments from drug companies, in 2007 she did not. In an article titled “Psychotropic Prescriptions in a Sample Including Both Healthy and Mood and Disruptive Disordered Preschoolers,” in the Journal of Child and Adolesent Psychopharmacology, Luby’s disclosure statement said:

The authors do not have any corporate, commercial, or financial relationships that pose conflicts of interest.

Also in 2007, Luby signed as an author to a “Special Communication” in the same journal written by a group of child psychiatrists called The Preschool Psychopharmacology Working Group. The purpose of their group, Luby and her colleagues wrote, was:

… to promote responsible treatment of young children, recognizing that this will sometimes involve the use of medications.

The other authors of that paper disclosed a wealth of company ties, including Eli Lilly, Organon, Forest Labs, GlaxoSmithKline, Wyeth-Ayerst, McNeil, Novartis, Pfizer, Bristol-Myers Squibb, Abbott, AstraZeneca, Sepracor, Cephalon, Sanofi-Aventis, Boehringer-Ingelheim, and Janssen. Regarding Luby, the paper said:

The other authors have no financial relationships to disclose.

In Luby’s 2009 editorial, she wrote:

The need for large-scale and focused studies of this issue is underscored by the high and increasing rates of prescriptions of atypical antipsychotics and other mood stabilizing agents for preschool children with presumptive clinical diagnosis of bipolar disorder.

She cited a paper by Harvard’s Dr. Joseph Biederman, who was subpoenaed by federal prosecutors investigating J&J’s promotion of Risperdal, much of which was allegedly off-label to children. Separately, hundreds of lawsuits have been filed alleging that Seroquel has dangerous side effects such as weight gain and diabetes.

*Correction: Shire originally said it had no contact with Luby in the prior two years.

* Related:
* Biederman’s Finances: He Names His Own Price, and It’s $550 an Hour
* AstraZeneca Q2: $593M Seroquel Legal Bill Taps Out Insurance; Income Charges Expected

Pharma-funded CME gets the lash [CME- def. - Continuing Medical Education]

Fierce Pharma
By tracy
Created Jul 30 2009 - 10:37am

Continuing medical education (CME [1]) has been bastardized by pharma funding, an HHS inspector general told Congress, and needs a complete overhaul. Lewis Morris, chief counsel for the HHS office of inspector general, said that industry doesn't just shape the courses, it has also used CME to promote off-label uses. And Morris was just the first of several witnesses expected to criticize industry-funded CME during a Senate Committee on Aging hearing.

Pharma-backed CME has grown by leaps and bounds. Dow Jones reports that industry funding for medical education has more than tripled over the past 10 years to $1.2 billion. That's more than half the courses many doctors are required to take to stay current. "CME has become an insidious vehicle for the aggressive promotion of drugs and medical devices," said Dr. Steve Nissen (photo [2]), the Cleveland Clinic cardiologist who rarely minces his words.

But others--including PhRMA--protest that the industry can offer the best, most up-to-date info on new treatments, and that drugmakers are an important part of medical education. Dr. Thomas Stossel of Harvard Medical School--who has started an organization balking at the current backlash against pharma funding and doc payments--told the committee that companies make an important contribution to scientific understanding of disease. "I want the best information. I don't care who pays for it," Stossel said (as quoted by Dow Jones). "The nonprofit societies just can't get up to speed fast enough."

The hearing is just the latest salvo in an ongoing battle over how much pharma funding is too much, and whether all financial ties between industry and doctors, academia, and CME should be disclosed. Medical schools and hospitals have established conflicts-of-interest policies, some of which are so strict they don't even allow reps to hand out logo notepads. Drugmakers have promised to disclose payments to doctors [3], and some have bowed out of CME funding. This particular Senate committee is considering legislation that would require companies to disclose doc payments. The debate is far from over.

Video-Risperdal Creating Lactating Breasts on Boys

CBS Evening News [click for graphic video]
– May 25, 2009 – Risperdal

Graphic CBS Video Covering Law Suit Against Johnson & Johnson for their Antipsychotic Risperdal Creating Lactating Breasts in Male Children

“Caution: Graphic Content:” For children “diagnosed” with ADD and bi-polar disorder, Risperdal is used for “treatment”. The side effects are putting them at serious risk.

2 Comments

2 Comments on Video

• Lisa Jones RN
  May 26, 2009 at 7:30 pm

  I cried the first time I had to give my son Risperdal. I am now homeschooling and have him OFF the medication. He is doing well….now.

  It is the pubic school system that pushes this !! When will it ever stop?

  Reply
• 
  

  Rikki
  May 27, 2009 at 2:04 pm

  It would never cross my mind to give a kid or anyone a substance to “solve” a behavioral problem.

  Why?

  Look around you – look at the ever-growing population of insane people and compare that to the ever-growing, billion-dollar drug sales business in the United States.

  People need to come to their senses and stop buying into this practice, this money-making racket, and justice needs to be brought once and for all to everyone involved in these CRIMINAL activities.