Drugmaker Eli Lilly pleaded guilty to illegally marketing its antipsychotic Zyprexa for elderly patients and paid $1.4 billion in criminal penalties and settlements. (AP file photo/Darron Cummings)
by Tracy Weber and Charles Ornstein
Sep. 16 2011
Two years ago, drugmaker Eli Lilly pleaded guilty to illegally marketing its blockbuster antipsychotic Zyprexa for elderly patients. Lilly paid $1.4 billion in criminal penalties and settlements in four civil lawsuits.
But a doctor named as a co-defendant in one suit - for allegedly taking kickbacks to prescribe the drug extensively at nursing homes - never was pursued.
Last year, Alpharma paid $42.5 million to settle federal allegations that it paid kickbacks to doctors to prescribe its painkiller Kadian.
"Health-care decisions must be based solely upon what is best for the individual patient and not on which pharmaceutical company is paying the doctor the biggest kickback," Rod J. Rosenstein, U.S. attorney for the District of Maryland, said in a statement announcing the settlement.
But the doctors accused of trading prescriptions for paid speaking gigs faced no consequences.
At least 15 drug and medical-device companies have paid $6.5 billion since 2008 to settle accusations of marketing fraud or kickbacks. However, none of the more than 75 doctors named as participants were sanctioned, despite allegations of fraud or of conduct that put patients at risk, a review by ProPublica found.
Reporters reviewed hundreds of pages of court records and interviewed current and former federal prosecutors, state medical board officials, attorneys for whistleblowers and, when possible, the doctors. For each doctor identified in a suit, ProPublica checked for state medical board discipline, penalties from the Medicare program and federal criminal charges.
In many of the cases, it appears that not even a cursory investigation was done to see whether the physicians had behaved inappropriately.
"Doctors have kind of gone under the radar," said Tavy Deming, a Philadelphia lawyer who represents drug company whistleblowers.
Amid concerns about the influence of drug company money on medicine, whistleblower lawsuits have emerged as a headline-grabbing tool for holding manufacturers accountable.
Yet, despite their power to secure large settlements from drugmakers, the suits have failed to resolve the culpability of physicians. Doctors often are not named as defendants, even though descriptions of their alleged misconduct are used to bolster the suits. And even when settling, many companies, including Alpharma, continue to deny the allegations.
After cases are resolved, the internal company documents used as evidence remain confidential, preventing further exploration of the physicians' behavior. Patients have no way of knowing whether their doctor's judgment has been compromised, and doctors may be tarnished by spurious accusations.
Medical boards, which normally pursue tips or complaints of wrongdoing, do not routinely scan for such cases. Justice Department lawyers, wary of spending more time and effort on a case, usually are not interested in going after lesser players.
Tony West, the assistant attorney general who oversees civil litigation nationwide for the Justice Department, declined through a spokeswoman to discuss the issue. In announcing settlements with the drug companies, however, West has said that kickbacks undermine doctors' credibility.
Sen. Charles E. Grassley (Iowa), the ranking Republican on the Judiciary Committee, said in a written statement that it takes "two sides to perpetuate this fraud" and that both need to be held accountable.
"Otherwise, regardless of how big of a civil settlement a drug company makes, the incentive to cheat the taxpayers will still be in place for those willing to take part," said Grassley, who has led investigations into conflicts of interest in medicine.
Doctors less-attractive targets
In recent years, pharmaceutical and medical-device companies have been barraged by whistle-blower lawsuits detailing how the pursuit of profit allegedly fueled fraud and corruption.
The suits are typically filed by former employees who say that the companies promoted drugs for unapproved uses or paid doctors to prescribe drugs or use medical devices. The suits seek to recover millions - even billions - of dollars spent on these products by government health programs.
The Justice Department joins the cases – known as "qui tam" suits, from Latin – if it believes they have merit. Whistle-blowers and their lawyers get a cut of any money collected. The government has come to rely on such cases to police companies' conduct.
For Justice Department lawyers, big drug companies make attractive targets. They are flush with profits and determined to avoid crippling legal defeats. Their bureaucratic sprawl often leaves an inadvertent trail of incriminating e-mail and memos. The massive financial settlements they are willing to pay are often modest in light of their annual sales and profits.
Zyprexa, for example, had U.S. sales of nearly $3 billion in 2010 alone. Kadian, Alpharma's painkiller, brought in nearly $263 million, according to IMS Health, which tracks prescription drug sales.
Also, the rules governing drug and device companies are strict: They are banned from pushing their products for uses not approved by the U.S. Food and Drug Administration.
Doctors, on the other hand, make particularly unattractive targets. Fearful of losing their licenses - and perhaps going to prison - they will devote every penny to their legal defenses. And juries like to think the best of physicians.
"It's a scorched-earth battle" for a doctor, said Michael Loucks, a former federal prosecutor in Massachusetts who led some of the nation's biggest health-care fraud investigations. "If he's convicted, it's not only a federal prison sentence, but he loses his license."
Rules governing doctors are less strict than those for drug companies. They are permitted to talk about unapproved uses of drugs or prescribe them when they believe a patient will benefit. To secure a conviction, prosecutors must show that doctors knowingly traded their prescription pads for money or perks.
Of course, doctors can and have been held accountable in other circumstances for negligence and malpractice if they prescribe the wrong drug for a patient or quantities that are harmful.
Another factor weighing against prosecution is burnout. After spending years taking on a drug company, many government attorneys are loath to tack on more time for a relatively minor victory.
Take the case of Maryland psychiatrist Peter Gleason. In 2006, federal prosecutors in New York charged him with pushing the narcolepsy drug Xyrem, also known as GHB or the "date-rape drug," for unapproved uses such as depression and fibromyalgia, a condition marked by chronic pain and fatigue.
Gleason vigorously challenged the charges, saying he believed in the benefits of the drug. He ultimately pleaded guilty to a single misdemeanor count of misbranding a drug for interstate commerce. In 2010, he was given one year of probation.
In July, Florida's health department filed an administrative complaint against him based on his conviction, apparently unaware that Gleason had committed suicide in February.
Evidence sealed at settlement
For concerned outsiders, the whistle-blower suits are often troublingly vague. Many don't provide enough specifics about physicians' roles to allow assessment of their veracity. Some offer only worrisome hints of doctors' misconduct.
But the case against Lilly and Florida psychiatrist George Jerusalem, unsealed in 2009, was rich with detailed allegations.
While purportedly receiving money and gifts from Lilly from 2001 to 2003, Jerusalem favored its antipsychotic Zyprexa, according to a case filed in federal court in Pennsylvania by Steven Woodward, a former Lilly sales representative.
Jerusalem was a consulting psychiatrist at more than 100 nursing homes in Florida's panhandle, treating 3,000 to 5,000 residents. According to the lawsuit, he prescribed more than $1 million worth of Zyprexa a year to them even though it was known to be potentially dangerous for older patients, according to the lawsuit.
Jerusalem had a change of heart, the suit said, when Lilly balked at hiring his son as a sales rep.
"As he had threatened, Dr. Jerusalem retaliated by immediately starting to switch his thousands of patients from Zyprexa" to a competitor's drug, the suit said. Sales of Zyprexa among Jerusalem's patients plummeted by 33 percent in one month, the lawsuit alleged.
Jerusalem did not return calls seeking comment. His wife, Tessie, who was also named as a defendant, said the accusations in the suit about trading prescriptions for favors are "not true."
Tessie Jerusalem, who managed his home office, said her husband gave only a few talks about Zyprexa over the years. If Woodward "can prove that Dr. Jerusalem made $50,000 from the company, oh my goodness," she said. "Where did he get that amount is beyond me."
Lilly settled this and three similar suits for $1.4 billion in 2009 and pleaded guilty to a misdemeanor charge for promoting Zyprexa in elderly populations as a treatment for dementia. Although Jerusalem was named as a defendant, the case against him was dropped when Lilly settled and there was no response from him in the court file. His case shows how hard it is for outsiders to get to the bottom of such allegations.
Once the Justice Department joins a case like this one, government lawyers have access to any evidence the whistle-blower brings. With their subpoena power, they also can secure patients' medical records, a breakdown of the drugs prescribed and a listing of a company's payments to physicians.
When a case is settled, however, any evidence typically remains confidential, is sealed or even returned to the drug company. The public is effectively left in the dark.
ProPublica's effort to substantiate the allegations against Jerusalem was inconclusive. Reporters sought Medicaid-prescribing data from Florida for Jerusalem. Those records show he had prescribed only a small amount of antipsychotics during 2003.
But the data might not reveal his true impact on the prescriptions of his patients. State records showed he had treated at least 1,557 patients enrolled in both Medicare and Medicaid (mostly nursing home residents) in 2003 alone.
It is common for consulting psychiatrists such as Jerusalem to recommend drugs for patients, while the actual prescriptions are then written by physicians who work as medical directors for the nursing homes. Assessing the allegations against Jerusalem would require a review of confidential patient medical records to show that he recommended a drug that was later prescribed by another doctor.
Prosecutors could conduct such a review with a subpoena, but federal patient privacy laws would shield the records from reporters.
Asked for substantiation, attorneys for Woodward said his claims were based on memory because he was not allowed to take his records when he was fired. They said the government found him to be a trustworthy source. Woodward did not return calls for comment.
Two government lawyers involved in the case wouldn't comment on it but said the Justice Department typically focuses on whether the allegations in a suit support a pattern of behavior by the company. The department does not vouch for whistle-blowers' specific claims about individual doctors.
Brian Kenney, a Woodward attorney, said he pushed prosecutors to pursue the psychiatrist because his conduct was "egregious," but they were not interested.
"Dr. Jerusalem's conduct is tantamount to elder abuse," the suit alleged.
In recent years, pharmaceutical and medical-device companies have been barraged by whistle-blower lawsuits detailing how the pursuit of profit allegedly fueled fraud and corruption.
The suits are typically filed by former employees who say that the companies promoted drugs for unapproved uses or paid doctors to prescribe drugs or use medical devices. The suits seek to recover millions - even billions - of dollars spent on these products by government health programs.
The Justice Department joins the cases – known as "qui tam" suits, from Latin – if it believes they have merit. Whistle-blowers and their lawyers get a cut of any money collected. The government has come to rely on such cases to police companies' conduct.
For Justice Department lawyers, big drug companies make attractive targets. They are flush with profits and determined to avoid crippling legal defeats. Their bureaucratic sprawl often leaves an inadvertent trail of incriminating e-mail and memos. The massive financial settlements they are willing to pay are often modest in light of their annual sales and profits.
Zyprexa, for example, had U.S. sales of nearly $3 billion in 2010 alone. Kadian, Alpharma's painkiller, brought in nearly $263 million, according to IMS Health, which tracks prescription drug sales.
Also, the rules governing drug and device companies are strict: They are banned from pushing their products for uses not approved by the U.S. Food and Drug Administration.
Doctors, on the other hand, make particularly unattractive targets. Fearful of losing their licenses - and perhaps going to prison - they will devote every penny to their legal defenses. And juries like to think the best of physicians.
"It's a scorched-earth battle" for a doctor, said Michael Loucks, a former federal prosecutor in Massachusetts who led some of the nation's biggest health-care fraud investigations. "If he's convicted, it's not only a federal prison sentence, but he loses his license."
Rules governing doctors are less strict than those for drug companies. They are permitted to talk about unapproved uses of drugs or prescribe them when they believe a patient will benefit. To secure a conviction, prosecutors must show that doctors knowingly traded their prescription pads for money or perks.
Of course, doctors can and have been held accountable in other circumstances for negligence and malpractice if they prescribe the wrong drug for a patient or quantities that are harmful.
Another factor weighing against prosecution is burnout. After spending years taking on a drug company, many government attorneys are loath to tack on more time for a relatively minor victory.
Take the case of Maryland psychiatrist Peter Gleason. In 2006, federal prosecutors in New York charged him with pushing the narcolepsy drug Xyrem, also known as GHB or the "date-rape drug," for unapproved uses such as depression and fibromyalgia, a condition marked by chronic pain and fatigue.
Gleason vigorously challenged the charges, saying he believed in the benefits of the drug. He ultimately pleaded guilty to a single misdemeanor count of misbranding a drug for interstate commerce. In 2010, he was given one year of probation.
In July, Florida's health department filed an administrative complaint against him based on his conviction, apparently unaware that Gleason had committed suicide in February.
Evidence sealed at settlement
For concerned outsiders, the whistle-blower suits are often troublingly vague. Many don't provide enough specifics about physicians' roles to allow assessment of their veracity. Some offer only worrisome hints of doctors' misconduct.
But the case against Lilly and Florida psychiatrist George Jerusalem, unsealed in 2009, was rich with detailed allegations.
While purportedly receiving money and gifts from Lilly from 2001 to 2003, Jerusalem favored its antipsychotic Zyprexa, according to a case filed in federal court in Pennsylvania by Steven Woodward, a former Lilly sales representative.
Jerusalem was a consulting psychiatrist at more than 100 nursing homes in Florida's panhandle, treating 3,000 to 5,000 residents. According to the lawsuit, he prescribed more than $1 million worth of Zyprexa a year to them even though it was known to be potentially dangerous for older patients, according to the lawsuit.
Jerusalem had a change of heart, the suit said, when Lilly balked at hiring his son as a sales rep.
"As he had threatened, Dr. Jerusalem retaliated by immediately starting to switch his thousands of patients from Zyprexa" to a competitor's drug, the suit said. Sales of Zyprexa among Jerusalem's patients plummeted by 33 percent in one month, the lawsuit alleged.
Jerusalem did not return calls seeking comment. His wife, Tessie, who was also named as a defendant, said the accusations in the suit about trading prescriptions for favors are "not true."
Tessie Jerusalem, who managed his home office, said her husband gave only a few talks about Zyprexa over the years. If Woodward "can prove that Dr. Jerusalem made $50,000 from the company, oh my goodness," she said. "Where did he get that amount is beyond me."
Lilly settled this and three similar suits for $1.4 billion in 2009 and pleaded guilty to a misdemeanor charge for promoting Zyprexa in elderly populations as a treatment for dementia. Although Jerusalem was named as a defendant, the case against him was dropped when Lilly settled and there was no response from him in the court file. His case shows how hard it is for outsiders to get to the bottom of such allegations.
Once the Justice Department joins a case like this one, government lawyers have access to any evidence the whistle-blower brings. With their subpoena power, they also can secure patients' medical records, a breakdown of the drugs prescribed and a listing of a company's payments to physicians.
When a case is settled, however, any evidence typically remains confidential, is sealed or even returned to the drug company. The public is effectively left in the dark.
ProPublica's effort to substantiate the allegations against Jerusalem was inconclusive. Reporters sought Medicaid-prescribing data from Florida for Jerusalem. Those records show he had prescribed only a small amount of antipsychotics during 2003.
But the data might not reveal his true impact on the prescriptions of his patients. State records showed he had treated at least 1,557 patients enrolled in both Medicare and Medicaid (mostly nursing home residents) in 2003 alone.
It is common for consulting psychiatrists such as Jerusalem to recommend drugs for patients, while the actual prescriptions are then written by physicians who work as medical directors for the nursing homes. Assessing the allegations against Jerusalem would require a review of confidential patient medical records to show that he recommended a drug that was later prescribed by another doctor.
Prosecutors could conduct such a review with a subpoena, but federal patient privacy laws would shield the records from reporters.
Asked for substantiation, attorneys for Woodward said his claims were based on memory because he was not allowed to take his records when he was fired. They said the government found him to be a trustworthy source. Woodward did not return calls for comment.
Two government lawyers involved in the case wouldn't comment on it but said the Justice Department typically focuses on whether the allegations in a suit support a pattern of behavior by the company. The department does not vouch for whistle-blowers' specific claims about individual doctors.
Brian Kenney, a Woodward attorney, said he pushed prosecutors to pursue the psychiatrist because his conduct was "egregious," but they were not interested.
"Dr. Jerusalem's conduct is tantamount to elder abuse," the suit alleged.
Medical boards don't follow up
When physicians are accused of sexual misconduct, medical malpractice or criminal behavior, medical boards typically launch investigations and impose public discipline if justified.
Medical-board officials in several states, however, said they could not recall any cases in which a doctor had been sanctioned for taking a kickback from a drug company or being part of a company's plan to market drugs "off-label" – for uses that are not approved by the FDA.
Russell Aims, chief of staff for Massachusetts Board of Registration in Medicine, said such cases are hard to prove because physicians can always claim they are prescribing and promoting a drug because they believe in it - not because of the money they are being paid.
"It's not like a wrong-site surgery, like sexual misconduct, like getting popped for a DWI," where the evidence is clear-cut, he said.
Further, many whistle-blower suits are filed in federal courts and never referred to state officials. Some former federal prosecutors said such suits should be routinely forwarded to state medical boards.
Attorney Marcella Auerbach, whose Florida practice represents whistle-blowers, said she is struck by the lack of interest in the cases by boards.
"There is absolutely no follow-up by any medical organization - not an e-mail, a phone call - ever that we've received in the office," she said. "No one's asked the question."
The federal government can fine doctors or strip them of their ability to bill federal health programs. But none of the physicians named in the suits settled since 2008 have faced such actions, according to a review this summer of a list of physicians excluded from billing Medicare and Medicaid.
In an earlier round of cases, the inspector general at the U.S. Department of Health and Human Services sanctioned three Florida doctors for seeking or receiving kickbacks from hip and knee-device makers. One was banned from Medicare and Medicaid for three years and fined $65,000. The others were fined $650,000 and $101,000, respectively.
None was disciplined by Florida's medical board.
Lewis Morris, chief counsel to the HHS inspector general, said doctors need to know there are repercussions."If you don't focus on doctors, this is a problem that will never end," he said.
He also acknowledged that he only has the resources to focus on the most glaring cases.
"I don't have a logical defense," Morris said. "We have a finite number of people to do a hell of a lot of work, so we can't get to every case we'd like to."
Doctors say they're unfairly labeled
Some doctors named in the suits say they've been unfairly branded. The inclusion of allegations in an official court document gives them a ring of truth, they say.
A 2008 whistle-blower lawsuit against Pfizer, for instance, names Delaware psychiatrist Neil Kaye as "one of the key champions of this nationwide fraudulent marketing scheme" involving the antipsychotic Geodon.
At least one of Kaye's PowerPoint presentations, the suit alleged, promoted the drug to treat a host of conditions for which it was not approved by the FDA.
Pfizer paid Kaye $4,000 a day plus expenses, said the suit, filed in Massachusetts. He even used his private helicopter to fly to speaking gigs "all at Pfizer's expense," the suit said.
Pfizer paid the government $2.3 billion in 2009 to resolve this and 10 other civil suits and a criminal case. As part of the settlement, a Pfizer subsidiary pleaded guilty to felony charges relating to the painkiller Bextra, which was pulled from the market in 2005. Kaye was named as a co-defendant but said he was never served with the suit nor was a party to the settlement.
A Pfizer spokesman said the allegations against Kaye are false. In an interview, Kaye said, "I've never off-label marketed. I never would."
Kaye said people have mentioned the suit to him. "I sometimes try to convince people that not everything that is on the Internet is the truth."
Jeffrey Bostic, a child psychiatrist in Boston, similarly was accused of being a cog in Forest Laboratories' marketing of its antidepressants Celexa and Lexapro for children. The drugs were not approved for that use.
In court papers filed in Massachusetts, the government said Bostic gave more than 350 Forest-sponsored talks and presentations.
"Dr. Bostic became Forest's star spokesman in the promotion of Celexa and Lexapro for pediatric use," the complaint said. The firm paid Bostic more than $750,000 in honoraria for his presentations on Celexa and Lexapro between 2000 and 2006, it said.
Bostic, who was not named as a defendant, said he was paid for his speeches but not $750,000. He said his talks were based on his experiences treating depressed children at a community mental-health center where he worked in southern New Hampshire.
Forest settled criminal and civil cases for $313 million in 2010. One of its subsidiaries pleaded guilty to a felony count of obstructing justice involving the thyroid hormone Levothroid, and separate misdemeanor counts of off-label promotion of Celexa as a treatment for pediatric patients and distributing Levothroid even though it was not approved.
The misdemeanor counts did not allege that the company intended to violate the law, the company said in a statement at the time.
"I've never had difficulty sleeping at night feeling I did anything inappropriate," Bostic said. "Maybe I'm deluded. There were no kickbacks."
When physicians are accused of sexual misconduct, medical malpractice or criminal behavior, medical boards typically launch investigations and impose public discipline if justified.
Medical-board officials in several states, however, said they could not recall any cases in which a doctor had been sanctioned for taking a kickback from a drug company or being part of a company's plan to market drugs "off-label" – for uses that are not approved by the FDA.
Russell Aims, chief of staff for Massachusetts Board of Registration in Medicine, said such cases are hard to prove because physicians can always claim they are prescribing and promoting a drug because they believe in it - not because of the money they are being paid.
"It's not like a wrong-site surgery, like sexual misconduct, like getting popped for a DWI," where the evidence is clear-cut, he said.
Further, many whistle-blower suits are filed in federal courts and never referred to state officials. Some former federal prosecutors said such suits should be routinely forwarded to state medical boards.
Attorney Marcella Auerbach, whose Florida practice represents whistle-blowers, said she is struck by the lack of interest in the cases by boards.
"There is absolutely no follow-up by any medical organization - not an e-mail, a phone call - ever that we've received in the office," she said. "No one's asked the question."
The federal government can fine doctors or strip them of their ability to bill federal health programs. But none of the physicians named in the suits settled since 2008 have faced such actions, according to a review this summer of a list of physicians excluded from billing Medicare and Medicaid.
In an earlier round of cases, the inspector general at the U.S. Department of Health and Human Services sanctioned three Florida doctors for seeking or receiving kickbacks from hip and knee-device makers. One was banned from Medicare and Medicaid for three years and fined $65,000. The others were fined $650,000 and $101,000, respectively.
None was disciplined by Florida's medical board.
Lewis Morris, chief counsel to the HHS inspector general, said doctors need to know there are repercussions."If you don't focus on doctors, this is a problem that will never end," he said.
He also acknowledged that he only has the resources to focus on the most glaring cases.
"I don't have a logical defense," Morris said. "We have a finite number of people to do a hell of a lot of work, so we can't get to every case we'd like to."
Doctors say they're unfairly labeled
Some doctors named in the suits say they've been unfairly branded. The inclusion of allegations in an official court document gives them a ring of truth, they say.
A 2008 whistle-blower lawsuit against Pfizer, for instance, names Delaware psychiatrist Neil Kaye as "one of the key champions of this nationwide fraudulent marketing scheme" involving the antipsychotic Geodon.
At least one of Kaye's PowerPoint presentations, the suit alleged, promoted the drug to treat a host of conditions for which it was not approved by the FDA.
Pfizer paid Kaye $4,000 a day plus expenses, said the suit, filed in Massachusetts. He even used his private helicopter to fly to speaking gigs "all at Pfizer's expense," the suit said.
Pfizer paid the government $2.3 billion in 2009 to resolve this and 10 other civil suits and a criminal case. As part of the settlement, a Pfizer subsidiary pleaded guilty to felony charges relating to the painkiller Bextra, which was pulled from the market in 2005. Kaye was named as a co-defendant but said he was never served with the suit nor was a party to the settlement.
A Pfizer spokesman said the allegations against Kaye are false. In an interview, Kaye said, "I've never off-label marketed. I never would."
Kaye said people have mentioned the suit to him. "I sometimes try to convince people that not everything that is on the Internet is the truth."
Jeffrey Bostic, a child psychiatrist in Boston, similarly was accused of being a cog in Forest Laboratories' marketing of its antidepressants Celexa and Lexapro for children. The drugs were not approved for that use.
In court papers filed in Massachusetts, the government said Bostic gave more than 350 Forest-sponsored talks and presentations.
"Dr. Bostic became Forest's star spokesman in the promotion of Celexa and Lexapro for pediatric use," the complaint said. The firm paid Bostic more than $750,000 in honoraria for his presentations on Celexa and Lexapro between 2000 and 2006, it said.
Bostic, who was not named as a defendant, said he was paid for his speeches but not $750,000. He said his talks were based on his experiences treating depressed children at a community mental-health center where he worked in southern New Hampshire.
Forest settled criminal and civil cases for $313 million in 2010. One of its subsidiaries pleaded guilty to a felony count of obstructing justice involving the thyroid hormone Levothroid, and separate misdemeanor counts of off-label promotion of Celexa as a treatment for pediatric patients and distributing Levothroid even though it was not approved.
The misdemeanor counts did not allege that the company intended to violate the law, the company said in a statement at the time.
"I've never had difficulty sleeping at night feeling I did anything inappropriate," Bostic said. "Maybe I'm deluded. There were no kickbacks."
No comments:
Post a Comment