Pharma Faces Fraud Charges, What About Docs?
23 CommentsBy Ed Silverman // September 20th, 2011 // 8:33 am
Amid the headlines and hoopla surrounding the stiff fines that many drugmakers have paid in recent years for off-label marketing, doctors almost always go untouched. To be specific, 15 drug and device makers paid $6.5 billion since 2008 to settle charges of fraud and kickbacks, but none of the more than 75 doctors who were named as participants were sanctioned, according to ProPublica.
As a result, the lawsuits never resolved the role played by physicians in which meds are prescribed for unapproved uses, despite allegations of fraud or conduct that put patients at risk, according to the news site, which scoured documents from courts, state medical boards, Medicare and other sources. Of course, doctors have the right to prescribe off label and to win a conviction, prosecutors must show a doctor knowingly wrote a prescription for money or other goodies.
Nonetheless, doctors often are not named as defendants, even though descriptions of their alleged misconduct are used to bolster the lawsuits pursued by the feds. Meanwhile, as ProPublica writes, patients have no way of knowing whether a doctor’s judgment has been compromised. At the same time, a doctor may claims his or her reputation has been hurt by unfounded accusations.
But why are doctors not pursued? They make unattractive targets. Fearful of losing their licenses and perhaps going to jail, they can be expected to fight hard. And, ProPublica notes, juries like to think the best of physicians. “It’s a scorched-earth battle” for a doctor, Michael Loucks, a former federal prosecutor in Massachusetts who led many of the biggest healthcare fraud investigations, tells ProPublica. “If he’s convicted, it’s not only a federal prison sentence, but he loses his license.”
There was one notorious case. In 2006, a Maryland psychiatrist named Peter Gleason was charged him with improperly promoting the Xyrem cataplexy drug, which is used to treat a sudden loss of muscle tone associated with narcolepsy. His talks were funded by Orphan Medical, which was bought by Jazz Pharmaceuticals. He talked the drug up to treat depression and fibromyalgia.
But he fought the charges and, recently, pleaded guilty to one misdemeanor with no intent, sentenced to one year of probation and paid a $25 fine. The 57-year-old physician, however, also saw his medical licenses suspended in Pennsylvania and California, and the accumulated weight of the events apparently led him to commit suicide, according to his sister (read here). This was, of course, an unexpected outcome, but protracted pursuits can also discourage prosecutors, who may view prosecution against a doctor as not worth the investment, especially after spending significant resources battling a large drugmaker.
And some cases may be hard to press, even when details are prevalent. ProPublica sites the case of Florida psychiatrist George Jerusalem, who allegedly received money and gifts from Eli Lilly from 2001 to 2003 to favor its Zyprexa antipsychotic, 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 and treated 3,000 to 5,000 residents, according to the lawsuit, which noted that he prescribed more than $1 million worth of Zyprexa annually, even though it was known to be potentially dangerous for older patients. But he supposedly changed his mind, after Lilly balked at hiring his son as a sales rep. And so, he retaliated by writing a large number of prescriptions for a rival med.
His wife tells ProPublica the accusations about trading prescriptions for favors are “not true.” Tessie Jerusalem, who managed his home office, says her husband gave only a few talks about Zyprexa over the years. Lilly settled this and 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, ProPublic writes.
One more example. A 2008 whistleblower lawsuit against Pfizer named Delaware psychiatrist Neil Kaye as “one of the key champions of this nationwide fraudulent marketing scheme” involving the Geodon antipsychotic. One of his PowerPoint presentations, the suit alleged, promoted the drug to treat various unapproved used. Pfizer paid Kaye $4,000 a day plus expenses, according to the lawsuit, and he used his private helicopter to fly to speaking gigs “all at Pfizer’s expense.”
Meanwhile, 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 Bextra painkiller, which was withdrawn six years ago. 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…I sometimes try to convince people that not everything that is on the Internet is the truth.”
Circumstances in each case can vary and, yes, as Lewis Morris, chief counsel to the HHS inspector general, tells ProPublica, “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.” At the same time, he notes that “if you don’t focus on doctors, this is a problem that will never end.” What do you think?
Should Doctors Be Pursued For Fraud Or Misconduct?
- Yes (94%, 165 Votes)
- No (6%, 10 Votes)
Total Voters: 175
Loading ...photo thx to jerome kassirer
olcranky
The bigger question is, why aren’t the medical licensing boards doing anything about this? If there’s enough evidence to even consider a criminal charge, then there should be enough evidence to warrant an evaluation and appropriate action from a state’s medical boards.
basement PharmD
what about my colleagues in the units who are paid a bonus each year on minimizing drugs costs? bottom line, they get paid by someone (influence?) to decide drug therapy that is in the interest of the institution, not the patient.
where is the horror?
xtian
Basement PharmD: the horror only goes one way. there is only horror when someone is influenced and makes money. There is no horror when someone is influenced to make it cheaper. Don’t you have your morals straight? {sarcasm off}
original industry insider
Medical licensing boards generally do not suspend a doctor’s license unless the doctor has been charged with a felony, and an egregious one at that. One example is that of Dr. David Arndt, an orthopedic surgeon in Boston, who in the middle of a spinal operation, 1) realized that he did not have the proper titanium rod to stabilize a spine, so he sawed the end off a screwdriver of similar length and inserted it instead, and 2) also left the operating table to cash a check before the bank closed. BTW, he also had a serious drug problem, which is one of the more common reasons for license suspension.
Phyllis
New Jersey Citizen Action and
The Citizen Policy & Education Fund of NJ
September 23, 2003
The pharmaceutical industry is the most profitable industry in New Jersey, the nation and throughout the world. The HealthCare Institute of New Jersey calls New Jersey “the epicenter of the pharmaceutical industry.
The drug industry, like most large industries, has tremendous access to elected officials :
Salient point
This post seems to mix civil & criminal law, going back & forth from litigation to prosecution. Of course, the DA’s office can prosecute a doctor based on Rx-writing, but the bar of being able to prove him guilty in a unanimous decision is extraordinarily high for offices with limited resources.
As for litigation–the “deep pockets” are with the drug company, not the doctor, so again it’s rarely worth the effort.
Jon
Despite the deaths of over 4,000 people and paying the largest criminal fine at the time in U.S. history, not one person from Eli Lilly has been prosecuted for hiding lethal side effects or illegal marketing of Zyprexa.
Read Spielmans, G.I., The promotion of olanzapine in primary care: An examination of internal industry documents, Social Science & Medicine (2009), doi:10.1016/j.socscimed.2009.05.0001
Perhaps once the government sets the corporate behavior bar higher than the ground, the docs may then be prosecuted as well.
Justice in MI
Part of the argument not to prosecute docs seems to be a version of “too big to fail.”
They will “fight hard” and juries tend to like them.
I understand the pragmatic issues of deep pockets and prosecution cost, but the cost of not prosecuting (including financial cost) must also be figured in.
Justice in MI
p.s. I’ve rarely seen such a one-sided vote on Pharmalot. Great we can mostly agree on some things!
Salient point
JiM-Afraid I don’t understand your comment. “Too big to fail” mainly concerns the risk that the entire financial structure would collapse if certain institutions fail. How does this relate to a single doctor in a court case?
And what specifically do you mean by “the cost of not prosecuting”? If I’m the AG, this is $0. Not sure how it gets less expensive than that.
Justice in MI
Salient–”too big to fail” was a metaphor (admittedly stretched)related to the reasons it seems prohibitive to prosecute docs–hard to win case, cost not worth nailing one person, the profession rarely rats on “one of our own.”
Thus, better to let it be than pursue what may be ideal from a justice perspective.
Costs of not prosecuting:
–provides tacit immunity to docs-on-take.
–may encourage others to push legal/ethical envelope.
–may cost pts injuries or deaths.
–costs of caring for such pts fall on someone, public or private.
–may subtlely or not so subtlely impact moral environment of medical practice–an extreme example of the kind of “entitlement” and “immunity” that characterizes medicine at its worst.
These are costs.
Tim
Justice in MI - the costs of not prosecuting docs that you list are the same as those incurred by not prosecuting individuals who work for pharma who are found to be hiding lethal side effects, actively pushing off-label market, and so forth.
Countless unnecessary deaths, a poor and mistrustful view of the industry, encouragement to continue the behavior, etc.
Transparency Values Thats the New GSK
Throw all of them in Jail! Pharma Reps, Executives and the Doctors!
original industry insider
Now that Lilly is going big time with Zyprexa in Russia, they can send the bad physicians to any of the many leftover Gulag forced labor camps in the remote regions of Siberia that have been empty since they were dissolved over 50 years ago. There’s a certain symmetry here. The Russians used to sentence politicians to psychiatric prison hospitals; now they imprison the miscreant psychiatrists themselves.
Salient point
JiM-So, if I’m the Attorney General, the cost of not prosecuting is $0. Correct?
Margaret Wilde
Big Pharma:
Destroys lives, health and happiness of countless innocent people with its toxic pharmaceutical junk
Corrupts the workers, the health professionals, the politicians, the lawyers et al who are tempted to abandon proper standards of ethics, morality, truth and decency by the lure of tainted money
Denudes national economies of cash, workers and resources producing and being paid vast sums for its toxic pharmaceutical junk
Pollutes the atmosphere and water courses with the effluent from its vile manufacturies
Is the greatest evil of the modern world.
original industry insider
No problem, Margaret. We can close down Big Pharma tomorrow, with all of its life saving medicines, just as you wish. We’ll just disappear and you can thank us for that. But please do us one favor: re-post in one year and tell us how many lives, health and “happiness of countless inocent people” have been destroyed” as a result of loss of access to their medications.
I can give you the numbers on the relatively small share of pharma’s contribution to overall health care GNP, meaning that we don’t “denude national economies of cash” as you stipulate, but I’ve learned that people who make emotionally based arguements rarely listen to the facts.
Justice in MI
Salient, obviously if you are a prosecutor and you don’t prosecute your direct cash cost is roughly zero. “Roughly” because there are still salaried hours that go into reviewing a case to decide whether to prosecute or not.
But the wider point has to do with providing corrupt docs immunity and whether there are “costs” to that–ones that play themselves out in pt. lives, trust in the profession, etc. etc. (Tim’s summary is pretty good.)
Pharma knows all too well what the cost of eroding trust are. It yields posts like some in this thread, with which I do not agree but which partly reflect, I think, a race to the bottom in certain segments of the industry re: the cat & mouse approach to regulation and accountability: playing _with_ the law rather than _by_ it.
CarrieOn
Margaret,
Tell me how you feel about Pharma when you can use a drug to avoid heart surgery, or you get cancer and need chemotherapy to stop the growth of said cancer. We’ll see how much you hate Pharma then.
Multiple Crimes
I was forced to witness multiple crimes committed against patients while I was training and working at an academic medical center. No one was held accountable or even tried to stop the assaults, except me. I was labeled “a loose cannon” by an out of control doctor who had to be removed from service but suffered no consequences. I have been subjected to fraud in my own clinical care for 25 years with lots of abuse, including rape, thrown in by my fellow doctors.
The USA is a criminal conglomerate full of self-interested political gangs without conscience.
So be it. Stop complaining. Don’t expect more.
original industry insider
Multiple crimes, the first time that I inserted a central venous line as a student at an academic medical center I accidentally caused a pneumothorax, although I was being supervised by a qualified attending who had done the procedure successfully many times. In order to correct my mistake I was allowed to insert a chest tube in order to reinflate the lung. The procedure was succesful and the patient went on to an uneventful recovery.
In an academic medical center, what you refer to as “crimes” most of us trained in that environment consider to be learning.
DirkS
Interesting read, that linked article about Peter Gleason. To see how a guy is called a corrupt Pharma shill by Evelyn Pringle for off-label use of Xyrem.
GHB (the active ingredient of xyrem) has been one of those products “big pharma doesn’t want you to know about”, with proponents praising all it’s virtues, from sleeping aid to antidepressant, a drug that doesn’t cause hang-overs or addiction and only has beneficial effects. Some have since discovered that long-term use can cause severe dependency, requiring a dose four to six times a day. But for many it still is that cheap natural (our body makes it’s own) substance, much better than the evil pharmaceuticals that doctors prescribe.
So reading Evelyn Pringle’s comments struck me as a bit ironic in this context. And I find her tone and statements contemptible, she stoops to the “journalistic” level one expects from a Rupert Murdoch tabloid. Thanks for (indirectly) bringing her name to my attention, one to add to my biased sources list.
BTW: wasn’t sure about this website as a whole, so I used an “Andrew Wakefield” search as guidance. Not too bad.
Amy G
I recently testified before the FDA as a mesh complication survivor following unprecedented voluntary reporting of serious adverse events associated with devices approved under the FDA’s 510(k) process, without clinical testing or research. The FDA’s Chocrane analysis noted that very few of the studies addressed adverse events and complications yet an independent advisory board, most paid by industry for speaking or research advised the FDA that they “felt” they had enough evidence to continue business as usual. Chairing this panel Dr. Falcone of Cleveland Clinic and recipient of Ethicon $1,000,000 grant-not considered a conflict of interest as he did not receive funds in the past 12 months. I’m certain I would forget who paid me $1,000,000….not!