CNN Special Investigations Unit
By Drew Griffin and Andy Segal,
April 2, 2010
CNN's Special Investigations Unit reveals internal company documents on Bextra and Pfizer's health care fraud. Watch at 3 p.m. ET Saturday on CNN.
VIEW VIDEO OF THIS STORY HERE:
www.youtube.com/watch?v=7ehUWAsSvFw
(CNN) -- Imagine being charged with a crime, but an imaginary friend takes the rap for you.
That is essentially what happened when Pfizer, the world's largest pharmaceutical company, was caught illegally marketing Bextra, a painkiller that was taken off the market in 2005 because of safety concerns.
When the criminal case was announced last fall, federal officials touted their prosecution as a model for tough, effective enforcement. "It sends a clear message" to the pharmaceutical industry, said Kevin Perkins, assistant director of the FBI's Criminal Investigative Division.
But beyond the fanfare, a CNN Special Investigation found another story, one that officials downplayed when they declared victory. It's a story about the power major pharmaceutical companies have even when they break the laws intended to protect patients.
Big plans for Bextra
The story begins in 2001, when Bextra was about to hit the market. The drug was part of a revolutionary class of painkillers known as Cox-2 inhibitors that were supposed to be safer than generic drugs, but at 20 times the price of ibuprofen.
Pfizer and its marketing partner, Pharmacia, planned to sell Bextra as a treatment for acute pain, the kind you have after surgery.
But in November 2001, the U.S. Food and Drug Administration said Bextra was not safe for patients at high risk of heart attacks and strokes.
The FDA approved Bextra only for arthritis and menstrual cramps. It rejected the drug in higher doses for acute, surgical pain.
Promoting drugs for unapproved uses can put patients at risk by circumventing the FDA's judgment over which products are safe and effective. For that reason, "off-label" promotion is against the law.
But with billions of dollars of profits at stake, marketing and sales managers across the country nonetheless targeted anesthesiologists, foot surgeons, orthopedic surgeons and oral surgeons. "Anyone that use[d] a scalpel for a living," one district manager advised in a document prosecutors would later cite.
A manager in Florida e-mailed his sales reps a scripted sales pitch that claimed -- falsely -- that the FDA had given Bextra "a clean bill of health" all the way up to a 40 mg dose, which is twice what the FDA actually said was safe.
Doctors as pitchmen
Internal company documents show that Pfizer and Pharmacia (which Pfizer later bought) used a multimillion-dollar medical education budget to pay hundreds of doctors as speakers and consultants to tout Bextra.
Pfizer said in court that "the company's intent was pure": to foster a legal exchange of scientific information among doctors.
But an internal marketing plan called for training physicians "to serve as public relations spokespeople."
According to Lewis Morris, chief counsel to the inspector general at the U.S. Department of Health and Human Services, "They pushed the envelope so far past any reasonable interpretation of the law that it's simply outrageous."
Pfizer's chief compliance officer, Doug Lanker, said that "in a large sales force, successful sales techniques spread quickly," but that top Pfizer executives were not aware of the "significant mis-promotion issue with Bextra" until federal prosecutors began to show them the evidence.
By April 2005, when Bextra was taken off the market, more than half of its $1.7 billion in profits had come from prescriptions written for uses the FDA had rejected.
Too big to nail
But when it came to prosecuting Pfizer for its fraudulent marketing, the pharmaceutical giant had a trump card: Just as the giant banks on Wall Street were deemed too big to fail, Pfizer was considered too big to nail.
Why? Because any company convicted of a major health care fraud is automatically excluded from Medicare and Medicaid. Convicting Pfizer on Bextra would prevent the company from billing federal health programs for any of its products. It would be a corporate death sentence.
Prosecutors said that excluding Pfizer would most likely lead to Pfizer's collapse, with collateral consequences: disrupting the flow of Pfizer products to Medicare and Medicaid recipients, causing the loss of jobs including those of Pfizer employees who were not involved in the fraud, and causing significant losses for Pfizer shareholders.
"We have to ask whether by excluding the company [from Medicare and Medicaid], are we harming our patients," said Lewis Morris of the Department of Health and Human Services.
So Pfizer and the feds cut a deal. Instead of charging Pfizer with a crime, prosecutors would charge a Pfizer subsidiary, Pharmacia & Upjohn Co. Inc.
The CNN Special Investigation found that the subsidiary is nothing more than a shell company whose only function is to plead guilty.
According to court documents, Pfizer Inc. owns (a) Pharmacia Corp., which owns (b) Pharmacia & Upjohn LLC, which owns (c) Pharmacia & Upjohn Co. LLC, which in turn owns (d) Pharmacia & Upjohn Co. Inc. It is the great-great-grandson of the parent company.
Public records show that the subsidiary was incorporated in Delaware on March 27, 2007, the same day Pfizer lawyers and federal prosecutors agreed that the company would plead guilty in a kickback case against a company Pfizer had acquired a few years earlier.
As a result, Pharmacia & Upjohn Co. Inc., the subsidiary, was excluded from Medicare without ever having sold so much as a single pill. And Pfizer was free to sell its products to federally funded health programs.
An imaginary friend
Two years later, with Bextra, the shell company once again pleaded guilty. It was, in effect, Pfizer's imaginary friend stepping up to take the rap.
"It is true that if a company is created to take a criminal plea, but it's just a shell, the impact of an exclusion is minimal or nonexistent," Morris said.
Prosecutors say there was no viable alternative.
"If we prosecute Pfizer, they get excluded," said Mike Loucks, the federal prosecutor who oversaw the investigation. "A lot of the people who work for the company who haven't engaged in criminal activity would get hurt."
Did the punishment fit the crime? Pfizer says yes.
It paid nearly $1.2 billion in a criminal fine for Bextra, the largest fine the federal government has ever collected.
It paid a billion dollars more to settle a batch of civil suits -- although it denied wrongdoing -- on allegations that it illegally promoted 12 other drugs.
In all, Pfizer lost the equivalent of three months' profit.
It maintained its ability to do business with the federal government.
Pfizer says it takes responsibility for the illegal promotion of Bextra. "I can tell you, unequivocally, that Pfizer perceived the Bextra matter as an incredibly serious one," said Doug Lankler, Pfizer's chief compliance officer.
To prevent it from happening again, Pfizer has set up what it calls "leading-edge" systems to spot signs of illegal promotion by closely monitoring sales reps and tracking prescription sales.
It's not entirely voluntary. Pfizer had to sign a corporate integrity agreement with the Department of Health and Human Services. For the next five years, it requires Pfizer to disclose future payments to doctors and top executives to sign off personally that the company is obeying the law.
Pfizer says the company has learned its lesson.
But after years of overseeing similar cases against other major drug companies, even Loucks, isn't sure $2 billion in penalties is a deterrent when the profits from illegal promotion can be so large.
"I worry that the money is so great," he said, that dealing with the Department of Justice may be "just of a cost of doing business."
Labels: bextra, boston us attorney, department of justice, drug companies, fda, fraud, geodon, off-label, Pfizer, pharmaceutical, Upjohn, us attorney
by Lane Lambert
Apr 10, 2010
BOSTON — Years before she became a board-certified psychiatrist, Dr. Kayoko Kifuji was diagnosing children as young as 2 as bipolar and hyperactive – and prescribing powerful cocktails of mood-altering drugs to quiet them.
By the time Kifuji finally passed the psychiatric board exam – on her fourth try – one of her youngest patients, Rebecca Riley, had a little more than a year to live. Her parents murdered the 4-year-old by overdosing her with one of the drugs Kifuji prescribed.
Both of Rebecca’s parents are in prison for her murder. Her mother, Carolyn, was convicted in February; her father, Michael, in March.
Now the spotlight is on the controversial doctor who testified in both trials in exchange for immunity. Kifuji and her employer, Tufts Medical Center, face a malpractice lawsuit filed by Norwell attorney Brian Clerkin, the court-appointed administrator for Rebecca’s estate, which was created for the benefit Rebecca’s brother and sister, who are now 14 and 9.
Glimpses into Kifuji’s background and treatment methods are part of a lengthy deposition she gave in December in the civil suit. The final pretrial hearing in the case is scheduled for June 1.
Kifuji diagnosed Rebecca Riley and her sister with mental illness and prescribed drugs for both girls and their brother. Prosecutors in the parents’ murder trials said the Rileys killed Rebecca because they couldn’t get disability payments for her, as they had with their two other kids.
According to the plaintiff’s lawyer in the malpractice suit, Benjamin P. Novotny, of the Boston firm Lubin and Meyer, Kifuji said she “trusted the mother” (Carolyn Riley) to tell her how the children were behaving and reacting to the drugs. She relied almost exclusively on what Carolyn told her about the kids when diagnosing them and ordering increasing amounts of drugs for them.
Kifuji also trusted the mother to keep tabs on Rebecca’s heart rate and blood pressure for signs of problems with the four drugs she was on. Kifuji, a pediatrician who later became a psychiatrist, told Novotny during the deposition that she didn’t realize she had a blood pressure cuff in her office and could check the girl’s vital signs herself until after Rebecca was dead. She said she didn’t take Rebecca’s pulse with her fingers because Carolyn Riley told her the child’s pulse “was within normal range.”
Kifuji also told Novotny during the deposition:
She prescribed clonidine – the drug that killed Rebecca – during the child’s first visit to control the “impulsivity” that Carolyn Riley described. Rebecca was 2 at the time.
She originally came to the United States from her native Japan in 1990 to research dust allergies in children. She switched her training to psychiatry when she went to New England Medical Center in 1994.
In 2000, she took a job at Baystate Medical Services in Springfield because it meant she wouldn’t have to return to Japan for two years and wait for an H-1 work visa.
She diagnosed dozens of children as bipolar or having attention deficit hyperactivity disorder (ADHD) or both, and estimated that she prescribed drugs for 99 percent of her pediatric patients.
She usually saw Rebecca for 20 minutes at each office visit because she was seeing all three Riley children in an hour.
She explained that some researchers believe the area of the brain called the amygdala is different in people with bipolar disease. But she admitted she didn’t know where the amygdala is in the brain.
Kifuji’s medical career has taken her from Tokyo to Detroit and Boston. She was living in Somerville as of December.
She grew up in Kumamoto, Japan, on the southwest tip of the island of Kyushu, and graduated from Tokyo Women’s Medical College in 1981.
She’s been a permanent legal resident of the U.S. since 1990, and has held a medical license here since 1999.
She worked at Baystate in Springfield from 2000-03. Her outpatients there included the Rileys’ two older children, whom she also diagnosed as bipolar with ADHD.
After Rebecca’s death in December 2006, Tufts Medical Center placed Kifuji on paid leave after the psychiatrist agreed not to practice medicine. The state Board of Registration in Medicine reinstated her license this past September after Plymouth County District Attorney Timothy Cruz announced that a grand jury would not bring criminal charges against her.
In January, Tufts reaffirmed its support for Kifuji and her treatment methods, saying she provided “appropriate” care to Rebecca Riley. Kifuji began seeing patients again in the fall. As of December, she was seeing five outpatients – four children and one adult – and working with a state-funded child psychiatric access program.
Lane Lambert is at llambert@ledger.com.
Kifuji’s treatment of Rebecca Riley
2004
Aug. 27, 2004: Carolyn Riley takes her daughter Rebecca to Kifuji for the first time. Within 20 minutes of meeting the then 2-year-old, she Kifuji diagnoses her with attention deficit hyperactivity disorder and prescribes clonidine as a sedative.
Sept. 1, 2004: Carolyn tells Kifuji over the phone that she has increased Rebecca’s clonidine dosage. Kifuji approves.
Oct. 1, 2004: Second office visit lasts 20 minutes.
Nov. 9, 2004: Refills clonidine prescription.
Dec. 9, 2004: Refills clonidine prescription.
2005
Jan. 3, 2005: Kifuji increases clonidine dosage over the phone.
Jan. 5, 2005: Third office visit. Kifuji reports Rebecca’s hyperactivity has worsened from mild to moderate. Increases clonidine dosage for the third time.
March 11, 2005: Carolyn tells Kifuji over the phone that Rebecca is having “lots of headaches,” a common side effect of clonidine.
May 3, 2005: Diagnoses 3-year-old Rebecca with bipolar disorder after mother tells her the girl has become “moody” and cries “over very small things easily.” Prescribes Depakote, an antiseizure drug.
June, July, August 2005: Refills prescriptions for clonidine and Depakote.
Aug. 4 and Aug. 31, 2005: Sees Rebecca in the office. No changes in diagnoses or dosage.
Oct. 27, 2005: Carolyn tells Kifuji she has increased Rebecca’s clonidine dosage again.
Kifuji tells her to decrease it and threatens to report Carolyn to the state. Kifuji increases Depakote dosage and prescribes Zyprexa, an antipsychotic.
Nov. 162005: Increases Depakote dosage.
December2005: Increases Zyprexa dosage.
2006
Jan. 9, 2006: Increases Zyprexa dosage again. Writes, “Present dose working well. No changes.”
Jan. 31, 2006: Increases Depakote dosage again after Carolyn reports that 3-year-old Rebecca is wetting the bed.
Feb. 16:, 2006 Prescribes Seroquel, an antipsychotic. Decreases Zyprexa. Notes Rebecca is gaining “too much weight and she’s still very aggressive and impatient.”
March 8, 2006: Increases Depakote dosage. Carolyn reports Rebecca is still having problems sleeping, is defiant and having tantrums.
May 24, 2006: Receives letter from a social worker concerned about the amount of drugs being given to the Riley children.
June 22, 2006: Increases Rebecca’s Seroquel dosage after 20-minute office visit.
July 20, 2006: Increases Depakote dosage after mother reports Rebecca was “getting into everything.”
Aug. 16, 2006: Tells Carolyn Riley she can increase or decrease drug dosages on her own. Changes clonidine prescriptions to 10-day supplies instead of month’s supply after Carolyn Riley says the last prescription was destroyed by water.
Aug. 21, 2006: Pharmacist tells Kifuji over the phone that Carolyn came in for pills but didn’t have doctor’s authorization. Kifuji gives it over the phone. Riley cannot explain 20 missing clonidine pills.
Sept. 15, 2006: Increases Rebecca’s Seroquel dosage again, the 13th drug increase she’s approved in two years. Tells mother that she can increase it even more.
Nov. 3, 2006: Returns call from the nurse at Rebecca’s preschool in Weymouth who says the 4-year-old is like a “floppy doll” and is so tired she can barely walk up the stairs. Nurse says she is concerned about how much medication Rebecca is on.
Nov. 10, 2006: Kifuji notes that mother says Rebecca’s sleep is improved and attributes it to Michael Riley having moved back in with the family at their new apartment in Hull.
Dec. 7, 2006: Sees Rebecca for the last time. Tells mother she’ll begin decreasing clonidine dosage if Rebecca continues to do well.
Dec. 13, 2006: Rebecca dies of clonidine overdose. Kifuji calls the Rileys and leaves a message for Carolyn.
Dec. 14, 2006: Carolyn calls Kifuji at 6:45 a.m. and leaves a message. Kufuji calls back at 4:45 p.m., 5:15 p.m., 6 p.m., 6:30 p.m. and at 7:20 p.m. when she reaches Carolyn. Kufiji says she called to ask what happened to Rebecca and see how Carolyn is doing.
Defending Dr. Kifuji
John P. Ryan, the lawyer for Dr. Kayoko Kifuji in the medical malpractice suit filed against her by Rebecca Riley’s estate, re cently talked to The Patriot Ledger about the case. Here is some of what he said: Here are some of the questions and answers from the interview:
Q: How do the issues in the civil case compare to those in the criminal cases against Rebecca’s parents?
A: “The issues in the criminal trials were narrowed by the nature of the claims in those cases, and the full expla nation of the medicines (pre scribed by Dr. Kifuji) will be developed in the civil case. It is unfortunate and ironic in the light of the convictions in the criminal trials that there has been an unwarranted displace ment of blame onto Dr. Kifuji.”
Q: Was Dr. Kifuji too quick or willing to prescribe drugs for a child so young?
A:“The medical records will disclose that Dr. Kifuji had numerous visits with the child (Rebecca Riley), and had the opportunity to personally view and assess the child and follow a treatment regime that is recognized and accepted in the complex field of pediatric psy chiatry. Dr. Kifuji is board-certified in pediatrics, general psychiatry and child and adolescent psychiatry. She is both academically trained and very experienced in her field. We expect in the civil case that competent and qualified expert opinion will both explain and support her treatment of this child.”
Q: Was it acceptable practice for Kifuji to approve an increase in the dosage of clonidine after Carolyn Riley told her (over the phone) that she had already started giving Rebecca more of the drug than originally prescribed?
A: “Her decision-making was based not only on observations from the mother, but from Dr. Ki fuji’s personal observations and experience in the field.”
Q: What’s your response to the harsh criticism of Kifuji from both prosecutors and defense attorneys during the Riley trials?
A: “The civil action is the proceeding in which Dr. Kifuji has the opportunity to present her affirmative side of the case, with appropriate expert analysis.”
Q: When will the civil trial begin?
A: “We are still probably as much as a year away from the trial on the civil case.”
Troubled toddler or drug-seeking mom?
Dr. Kayoko Kifuji diagnosed then 2-year-old Rebecca Riley with attention deficit hyperactivity disorder after Kifuji’s first 20-minute visit with the child in 2004. That’s when she first prescribed clonidine, the drug that killed Rebecca in 2006. Kifuji had already diagnosed Rebecca’s sister with ADHD and bipolar disorder and prescribed many of the same drugs for her and their brother.
Here are some of Kifuji’s treatment notes on Rebecca, which are in a deposition Kifuji gave in December in a pending medical malpractice suit:
* A week before her first appointment with Rebecca, Kifuji wrote: “Called mother. Two years old. Very hyper. All over. Last couple of week, not sleeping but keep going like her brother who was not sleeping when he was small.”
* Kifuji described Rebecca during the first office visit:
“Two-and-half-year-old female with history of colic and not sleeping much in her infancy developed sleep disturbance again. Hyperactivity on and off since four months ago. Then consistently hyper all the time. Climbs up to top of jungle gym without any fears and thinking. Gets into everything. Just walk up to someone and smack them. Never gets aggressive. Hits kicks and spits when she’s being disciplined and laughs. Started to say things scared her. Whines and fusses a lot.”
* During the same visit when Rebecca was 21/2 years old, Kifuji described the toddler as dysarthric, meaning she could not properly pronounce some words. She also described Rebecca as a “happy” child with a “bright affect.”
* During her second 20-minute visit with Rebecca, in October 2004, Kufuji wrote: “Doing okay. A bit tired since yesterday. Coming down on flu. Fine as long as she takes clonidine. Sleeps throughout. Without clonidine gets very hyper and impulsive.”
She also wrote: “(Rebecca) is loud and silly at times while she was playing with her sister but redirectable.”
* During later visits, Kifuji described Rebecca as “very impulsive.” She explained that Rebecca’s mother said the girl: “Climbs up on top of bureau. Tantrums or sobbing when she was told to clean up her toys” and “she wasn’t listening to her mother.” Rebecca was 3.
* Three months after diagnosing Rebecca as bipolar, Kifuji noted that the family is under increased stress because Michael Riley has been accused of sexually abusing a girl. She writes of Rebecca: “Gets aggressive to her sibs with hitting and kicking. Can’t go out to play with kids in neighborhood due to the allegations, and they had pressure to move out from (Weymouth).”
* Asked why she didn’t report Carolyn Riley to child welfare authorities after learning that the mother had increased the children’s doses at least twice without checking with her first, Kifuji said: “I just can’t report to the DSS. I need to ... my role is to work with the parent and not judging them.”
* Asked if she ever told Carolyn not to give Rebecca cold medicine on top of all the drugs the child was on, Kifuji says no, “but it’s because Rebecca didn’t get sick, and I was never asked ...”
Kifuji’s medical career
1981: Graduates from Tokyo Women’s Medical College in Japan.
May 1981-April 1983: Resident in pediatrics at Toyko Women’s Medical College.
May 1983-April 1987: Fellow in pediatric allergy at Toyko Women’s Medical College.
Feb. 1991-June 1994: Researcher on dust allergies in children at Henry Ford Hospital in Detroit.
1994-1999: Resident in pediatrics/psychiatry/child psychiatry at New England Medical Center, Boston.
June 1999: Receives Massachusetts medical license.
October 1999: Board-certified in pediatrics.
February 2000-July 2003: Worked at Baystate Medical Services in Springfield.
August 2003: Began job at Tufts Medical Center, Boston.
October 2005: Board-certified in general psychiatry.
November 2006: Board-certified in adolescent psychiatry.
February 2007: Agrees not to practice following the death of Rebecca Riley.
July 2009: A Plymouth County grand jury decides not to return an indictment against Kifuji, clearing her of criminal charges in Rebecca’s death.
September 2009: Returns to practice after state Board of Registration in Medicine reinstates her medical license.
Copyright 2010 The Patriot Ledger. Some rights reserved
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---Comments (12)---
How the hell can ANYONE tell if a 2 year old is bipolar?
'She explained that some researchers believe the area of the brain called the amygdala is different in people with bipolar disease. But she admitted she didnt know where the amygdala is in the brain.'
I doubt this quack could find her ass with both hands with a cowbell duct taped to it. And the board gave her license back?
rcamom
2 days ago
when my children were small, it was called the 'terrible two's'. That poor baby. The doctor should lose her license to prescribe medication.
MyChristmas
2 days ago
Its time for the state to step in and go through this so called doctors files and review EVERY case that involves children she prescribed meds to. She is most certainly a danger to children and an embarassment to the medical profession.
I'm going to say this for my 1st time as a poster here on the ledger 'DEPORT HER'
DannyHaszard
Zyprexa,as well as the other atypical antipsychotics, are being prescribed for children, even though this is an unapproved, off-label use.
A report by Dr. Cooper at Vanderbilt University states that 2.5 million children are now taking atypical antipsychotics. Over half are being given them for Attention Deficit Hyperactivity Disorder. Perhaps it is statistics like these that caused the FDA to finally require warnings on the labels of the ADHD drugs.
The use of atypical antipsychotics for children should be banned.
--
Daniel Haszard www.zyprexa-victims.com
jenjambam
2 days ago
I was told my daughter was ADHA in third grade. I don't give a **** what the school said, took her to her pediatrician she did not agree. School advised to get a dianosis whether or not I wanted meds, which they were not recommending, just so she could get some benefits when it came to test times.Took her to a phyc Dr. to get diagnosis, she said yup but just slite case, no recommendation for meds. Thank God, I could care less if she bounces of the wall while doing home work as long as it get done. And it does, just takes a bit longer than others. Worth every minutie to have her alive.
nemesis
2 days ago
Two year-olds, I find hard to believe , are 'bi-polar'.....they are just 'two year-olds, acting like two year-olds......This Doctor (choke) should have her license revoked.
DannyHaszard
2 days ago
Eli Lilly has made 40 billion on 10 dollar a pill Zyprexa and it was way oversold and caused diabetes and in some cases sudden death. Zyprexa was pushed by Lilly Drug Reps.
They called it the 'Five at Five' (5 mg at 5 pm to keep nursing home patients subdued and sleepy) and 'VIVA ZYPREXA' (Zyprexa for everybody) campaigns to off label market Eli Lilly Zyprexa as a fix for unapproved usage.I am a living example of Zyprexa gone/done wrong was given it 1996-2000 off-label for PTSD got sudden high blood sugar A1C 14.7 in January 2000.The stuff was worthless for my condition PTSD and cost me thousands in co-pays gave me diabetes.
--
Daniel Haszard
Oscar Wood
2 days ago
The question still has to be asked does the doctor speak English well enough to undersatnd what is going on? She is another immigrant. Remember she passed her bards on the 4th try. That's right the fourth try. Any decent person would have quit and joined the pharmaceutical industry, the dumping ground of not quite so bright medical minds. it is a disgrace that she is able to see patients. Oscar
Fiend4Mojitos
2 days ago
Didn't know there was a BP Cuff in her office?
Does she know what a BP Cuff looks like?
sisyphus
2 days ago
Tufts Medical Center and the state board of registration for medicine should be ashamed for reinstating this horrible person who somehow managed to get a medical degree. Kudos to the reporters at the Ledger who gathered all this information. I am glad they are keeping this issue in the news.
21 hours ago
She's as guilty as guilty does....poorly trained and not too bright. I don't trust foreign born medical practioner's in general and even less so those involved in the psychiatric profession. They have caused much harm to young and old. May God help her she is hellbound!
kimnjulia
17 hours ago
Today (April 11) would have been Rebeccas 8th birthday. Kifuji may have been granted immunity here - but heaven help her. Karmas organic and on duty too.