We've had several recent posts on the Avandia revelations, most of which emanated from the investigation of the staff of the Senate Finance Committee. Their report can be accessed in full at:
http://finance.senate.gov/newsroom/ranking/release/?id=bc56b552-efc5-4706-968d-f7032d5cd2e4
(see links-- the full report is more than 300 pages of which only about 15 is the report itself, and the bulk being the supporting documents)
Another helpful overview and summary is provided by the Australian journalist Ray Moynihan in BMJ (subscription required). Moynihan summarizes the Senate committee report findings, then gives GlaxoSmithKline's rebuttal, which includes charges that more recent studies are showing that Avandia creates no additional risk of heart attack. Moynihan responds by noting that these more recent studies are all being funded by GSK, and he refers to the study we already posted about in BMJ, showing that authors with financial ties to drug companies were three times more likely to be writing favorably about Avandia's risk profile than were financially nonconflicted authors. Moynihan also shrewdly goes to the real root of the matter--it is not that Avandia is such an all-fired-great drug for diabetes that we should be using it until it is definitely proved to be harmful. In fact Avandia has never been shown effectively to prevent any of the serious complications of diabetes, and so there is a real question as to why it ever should have become a widely used drug in the first place--were it not for overmarketing. In such an instance any hint that the drug might be unsafe should be sufficient grounds to yank it from the market.
Moynihan R. Rosiglitazone, marketing, and medical science. BMJ 340:785-789, 10 April 2010.
Friday, April 9, 2010
Wednesday, April 7, 2010
What's Driving Overuse of Complex Spinal Surgery?
An important paper in the current issue of JAMA:
http://jama.ama-assn.org/cgi/content/full/303/13/1259?home
(at least for now the journal seems to be providing free access to this article)--looks at Medicare billing data for various forms of surgery for spinal stenosis from 2002 to 2007. The chief author, Dr. Richard A. Deyo of Oregon Health and Science University, might well be dubbed "Doctor Back Pain" for his many publications on that topic, many of which demonstrating conclusively that more conservative and cheaper treatments for back pain work as well as more invasive and expensive ones.
The focus of the present article is on the very common condition of spinal stenosis, which basically means a narrowing of a bony canal through which nerve roots come, resulting in pain due to compressed (pinched) nerves. This type of back pain usually does not get better without surgery. The available research data show that the simplest and least invasive surgery, scrounging out the edges of the bony canal to decompress the nerve, works as well as more complex surgeries that involve fusing one or more vertebrae together. (At least, there are no good data today to demonstrate a clear superiority to the more complex surgical techniques.)
Deyo and colleagues showed that from 2002 to 2007, while the overall rate of surgery for spinal stenosis did not increase, the percentage of cases in which the complex procedures were used climbed from 1.3% to 19.9%. The use of more complex surgical approaches was correlated with a higher rate of complications, a greater risk of death, and more than three times greater hospital charges. In short, a type of surgery that has no proof of added benefit went from a tiny blip on the radar to nearly one-fifth of all surgeries of that type, adding to patient risk and greatly padding the total Medicare bill.
What caused this? Deyo and colleagues are reticent, as is appropriate as just staring at sheets of Medicare data cannot answer cause-and-effect questions. But they mention among the possibilities first, the fact that medical device makers have heavily promoted the implants, cement, and other paraphernalia required for the more complex surgeries (the price for which can add up to as much as $50,000 per operation), and second, that surgeons get paid a good deal more for the complex procedures. (This reminds us of George Bernard Shaw's classic statement in The Doctor's Dilemma in 1911, that if you pay a surgeon to cut off your leg, and don't pay him not to cut it off, don't be surprised if the fellow cuts off your leg.)
A bit of further insight is added in an accompanying editorial:
http://jama.ama-assn.org/cgi/content/full/303/13/1309?home
--by Dr. Eugene J. Carragee of Stanford. Dr. Caragee notes that the difference in surgical fees between the simple decopmpression operation and the more complex surgeries may be on a ten-fold scale. He also notes that there are times when it is technically harder to do the simpler than the more complex surgery--to go in and scrounge out the bone without disrupting the stability of the vertebra or the ligaments may be more difficult than simply slapping on an implant or a graft. So today, he suggests, we are actually paying back surgeons less to do the more difficult (but often more desirable) procedure.
The whole story here is complicated but seems to typify how drug or device industry marketing seldom operates in a vacuum. In this case the heavy promotion of expensive devices interacts with a perverse incentive structure to produce outcomes that cost us all a lot of money and that expose patients to unneeded risk.
Finally, one has to note the apparent lack of interest of the average medical specialist in basic epidemiology. In HOOKED I cited psychiatrist David Healy on this matter. As drug companies promoted the newer generation of antidepressant drugs aggressively in the 1990s, the diagnosis of depression became so much more common that eventually the WHO announced that depression was the second largest cause of disability among all diseases. Psychiatrists greeted that news with great joy, as if making depression that common made them that much more important. Healy noted their apparent disinterest in the basic question--just what made that many people so much more depressed all at once? How does one scientifically account for the diagnosis of depression growing by leaps and bounds? Similarly, if Deyo et al. are correct, the back surgery community as apparently been very little interested in or concerned about whatever made the complex (and more remunerative) forms of back surgery so much more necessary in 2007 than they were in 2002.
http://jama.ama-assn.org/cgi/content/full/303/13/1259?home
(at least for now the journal seems to be providing free access to this article)--looks at Medicare billing data for various forms of surgery for spinal stenosis from 2002 to 2007. The chief author, Dr. Richard A. Deyo of Oregon Health and Science University, might well be dubbed "Doctor Back Pain" for his many publications on that topic, many of which demonstrating conclusively that more conservative and cheaper treatments for back pain work as well as more invasive and expensive ones.
The focus of the present article is on the very common condition of spinal stenosis, which basically means a narrowing of a bony canal through which nerve roots come, resulting in pain due to compressed (pinched) nerves. This type of back pain usually does not get better without surgery. The available research data show that the simplest and least invasive surgery, scrounging out the edges of the bony canal to decompress the nerve, works as well as more complex surgeries that involve fusing one or more vertebrae together. (At least, there are no good data today to demonstrate a clear superiority to the more complex surgical techniques.)
Deyo and colleagues showed that from 2002 to 2007, while the overall rate of surgery for spinal stenosis did not increase, the percentage of cases in which the complex procedures were used climbed from 1.3% to 19.9%. The use of more complex surgical approaches was correlated with a higher rate of complications, a greater risk of death, and more than three times greater hospital charges. In short, a type of surgery that has no proof of added benefit went from a tiny blip on the radar to nearly one-fifth of all surgeries of that type, adding to patient risk and greatly padding the total Medicare bill.
What caused this? Deyo and colleagues are reticent, as is appropriate as just staring at sheets of Medicare data cannot answer cause-and-effect questions. But they mention among the possibilities first, the fact that medical device makers have heavily promoted the implants, cement, and other paraphernalia required for the more complex surgeries (the price for which can add up to as much as $50,000 per operation), and second, that surgeons get paid a good deal more for the complex procedures. (This reminds us of George Bernard Shaw's classic statement in The Doctor's Dilemma in 1911, that if you pay a surgeon to cut off your leg, and don't pay him not to cut it off, don't be surprised if the fellow cuts off your leg.)
A bit of further insight is added in an accompanying editorial:
http://jama.ama-assn.org/cgi/content/full/303/13/1309?home
--by Dr. Eugene J. Carragee of Stanford. Dr. Caragee notes that the difference in surgical fees between the simple decopmpression operation and the more complex surgeries may be on a ten-fold scale. He also notes that there are times when it is technically harder to do the simpler than the more complex surgery--to go in and scrounge out the bone without disrupting the stability of the vertebra or the ligaments may be more difficult than simply slapping on an implant or a graft. So today, he suggests, we are actually paying back surgeons less to do the more difficult (but often more desirable) procedure.
The whole story here is complicated but seems to typify how drug or device industry marketing seldom operates in a vacuum. In this case the heavy promotion of expensive devices interacts with a perverse incentive structure to produce outcomes that cost us all a lot of money and that expose patients to unneeded risk.
Finally, one has to note the apparent lack of interest of the average medical specialist in basic epidemiology. In HOOKED I cited psychiatrist David Healy on this matter. As drug companies promoted the newer generation of antidepressant drugs aggressively in the 1990s, the diagnosis of depression became so much more common that eventually the WHO announced that depression was the second largest cause of disability among all diseases. Psychiatrists greeted that news with great joy, as if making depression that common made them that much more important. Healy noted their apparent disinterest in the basic question--just what made that many people so much more depressed all at once? How does one scientifically account for the diagnosis of depression growing by leaps and bounds? Similarly, if Deyo et al. are correct, the back surgery community as apparently been very little interested in or concerned about whatever made the complex (and more remunerative) forms of back surgery so much more necessary in 2007 than they were in 2002.
Monday, April 5, 2010
U. Minnesota--Evading Responsibility for Reprehensible Behavior
My esteemed ethicist colleague at the University of Minnesota, Carl Elliott, deserves credit on many points. He's been an astute commentator on the corrupting influences of corporate cash on medical practice and research. He also has considerable courage--willing to point fingers and name names not only among our own bioethics colleagues who accept industry money, but also at his own institution when it misbehaves (as unfortunately it has tended to do often of late).
I had heard a bit in the past about the Dan Markingson case in Minneapolis, but until Carl recently gave a lecture on the topic (at the National Undergraduate Bioethics Conference a week ago at the University of Puget Sound, Tacoma, WA), I didn't quite grasp all the essential pieces. The public record is nicely summarized in a newspaper article and in Ed Silverman's summary on Pharmalot:
http://www.pharmalot.com/2008/05/whos-delusional-a-university-doc-a-clinical-trial/
http://www.twincities.com/ci_9292549?IADID=Search-www.twincities.com-www.twincities.com&nclick_check=1
Carl himself added a few extra details that will be forthcoming, he tells me, in a new book he's working on. The following account includes all the details I am aware of from these various sources.
Dan Markingson was the only son of Mary Weiss and seemed to be perfectly balanced mentally. She was therefore shocked when she traveled from Minnesota to visit him in California in the summer of 2003 and found him claiming that aliens had damaged his house and that a secretive world order was planning a "storm" in which Dan would be ordered to kill people. With some difficulty she managed to get him back to Minnesota and then (when his delusions became worse and he started to talk about killing Mary as part of the "storm") took him to the local hospital on Nov. 12, 2003. The hospital had no psychiatric beds open and transferred Dan to the University of Minnesota Medical Center, Fairview.
Dan was evaluated at Fairview by a faculty psychiatrist, Dr. Stephen Olson. Dr. Olson petitioned the court to commit Dan involuntarily because he was unable to make decisions about his care and posed a danger to himself or others. Within a week, however, Dr. Olson was telling the court a different story, saying that Dan had improved enough to warrant a new recommendation. The court agreed and dropped the involuntarily commitment order, contingent upon Dan's adhering to his doctor's treatment program. That program, it now turned out, was to participate in a national study of anti-psychotic drugs called CAFE. According to the study, Dan would be randomly assigned to one of three standardly used drugs for psychosis, Seroquel, Zyprexa, or Risperdal (in the end, it was found, he was randomized to Seroquel).
These events take on a different coloration when you look at some of the relevant financial arrangements. The U. Minn. Department of Psychiatry had agreed to participate as one of the 26 sites in the CAFE study, and if they completed their role in the study, stood to earn $327,000, some of which would go personally to Dr. Olson. Specifically, Dan Markingson as a research subject was worth $15,000 to the University. AstraZeneca, sponsor of CAFE, had been on Minnesota's case earlier for insufficient subject enrollment. (The protocol called for newly diagnosed schizophrenics who had never been treated previously with drugs, a difficult-to-identify group.) Until Minnesota launched a special unit in its hospital specifically to screen all patients for potential research enrollment, the company had threatened to eliminate them from CAFE, putting their hoped-for funding in jeopardy.
From Mary Weiss's viewpoint, things were not going well at all. She was flabbergasted when told that her son, who was delusional and far from his normal self, suddenly was sufficiently competent to consent to a research trial. As she visited him over the ensuing weeks, she became convinced that whatever drug he was randomized to was simply not working, and that he needed a different treatment. She wrote numerous letters and protested in person to the Department of Psychiatry, which ignored her input totally. (It is pretty standard for psychiatrists, in my limited experience, to decide that the family members of psychiatric patients are either mentally disturbed themselves, or else are part of the environment that may have caused the psychiatric disorder in the patient, leading them to view the family member more as an enemy than an ally in therapy.) On May 8, 2004, Dan Markingson killed himself by mutilating his own body with a knife, leaving a note behind, "I went through this experience smiling!"
Dr. Olson and his colleagues expressed regret but not surprise that such a severely disturbed patient should have committed suicide, and noted that the research study could not have caused the death, as the three drugs were all in common use and in almost all circumstances, Dr. Olson would have started Dan on one of those three drugs, trial or no trial. In theory the research trial was to Dan's advantage because it assured closer monitoring. From Mary's point of view, Dan had been effectively coerced into the trial, being told that he'd be committed again unless he consented, and was unable at that point in time to make rational decisions about enrollment or nonenrollment. While the trial did not perhaps dictate the initial treatment, it certainly became a factor in keeping Dan on a treatment for many months while (as per Mary) his symptoms actually were worsening, as the University stood to lose their funding if he had been taken off the study drug.
The next to last chapter was that Mary Weiss sued the University and Dr. Olson. The court threw out the suit against the University arguing statutory immunity for a state institution. She collected, she said, $75,000 in a settlement with Dr. Olson which only went to pay her outstanding legal bills.
The last chapter is an especially sad commentary on the University as poor citizen of the community. Having gotten off the hook via statutory immunity, we would have expected the University to declare victory and retire from the field. Instead the U. took the unusual step of countersuing Mary Weiss to collect $57,000, which it claimed were its own legal fees in defending against her suit. Mary had no money to defend herself against the countersuit. She was forced to reach a settlement with Minnesota, one provision of which was to promise not to appeal her original ruling.
What are we to make of this countersuit? In HOOKED I discuss the phemonenon of SLAPP, "strategic lawsuit against public participation." A SLAPP happens when a powerful party with deep pockets but with a very weak legal position sues a citizen who's making noise about the issue in a way that's uncomfortable for the powerful party. The suit may have no real legal merit and is almost sure to lose when and if it comes before a judge. But the weaker party has no financial ability to pursue the lawsuit to its conclusion, and is forced to settle as quickly as possible. This usually is a strategy for sending a chilling message to anyone bold enough to criticize the powerful party--don't do it, says the message, or you may just find yourself entangled in a lawsuit from which it will take all of your money to extricate yourself. In this specific case, the purpose of SLAPP might have been to prevent an appeal that the University feared it would lose, especially if the behavior of Dr. Olson was viewed in light of the financial conflicts of interest.
I had heard a bit in the past about the Dan Markingson case in Minneapolis, but until Carl recently gave a lecture on the topic (at the National Undergraduate Bioethics Conference a week ago at the University of Puget Sound, Tacoma, WA), I didn't quite grasp all the essential pieces. The public record is nicely summarized in a newspaper article and in Ed Silverman's summary on Pharmalot:
http://www.pharmalot.com/2008/05/whos-delusional-a-university-doc-a-clinical-trial/
http://www.twincities.com/ci_9292549?IADID=Search-www.twincities.com-www.twincities.com&nclick_check=1
Carl himself added a few extra details that will be forthcoming, he tells me, in a new book he's working on. The following account includes all the details I am aware of from these various sources.
Dan Markingson was the only son of Mary Weiss and seemed to be perfectly balanced mentally. She was therefore shocked when she traveled from Minnesota to visit him in California in the summer of 2003 and found him claiming that aliens had damaged his house and that a secretive world order was planning a "storm" in which Dan would be ordered to kill people. With some difficulty she managed to get him back to Minnesota and then (when his delusions became worse and he started to talk about killing Mary as part of the "storm") took him to the local hospital on Nov. 12, 2003. The hospital had no psychiatric beds open and transferred Dan to the University of Minnesota Medical Center, Fairview.
Dan was evaluated at Fairview by a faculty psychiatrist, Dr. Stephen Olson. Dr. Olson petitioned the court to commit Dan involuntarily because he was unable to make decisions about his care and posed a danger to himself or others. Within a week, however, Dr. Olson was telling the court a different story, saying that Dan had improved enough to warrant a new recommendation. The court agreed and dropped the involuntarily commitment order, contingent upon Dan's adhering to his doctor's treatment program. That program, it now turned out, was to participate in a national study of anti-psychotic drugs called CAFE. According to the study, Dan would be randomly assigned to one of three standardly used drugs for psychosis, Seroquel, Zyprexa, or Risperdal (in the end, it was found, he was randomized to Seroquel).
These events take on a different coloration when you look at some of the relevant financial arrangements. The U. Minn. Department of Psychiatry had agreed to participate as one of the 26 sites in the CAFE study, and if they completed their role in the study, stood to earn $327,000, some of which would go personally to Dr. Olson. Specifically, Dan Markingson as a research subject was worth $15,000 to the University. AstraZeneca, sponsor of CAFE, had been on Minnesota's case earlier for insufficient subject enrollment. (The protocol called for newly diagnosed schizophrenics who had never been treated previously with drugs, a difficult-to-identify group.) Until Minnesota launched a special unit in its hospital specifically to screen all patients for potential research enrollment, the company had threatened to eliminate them from CAFE, putting their hoped-for funding in jeopardy.
From Mary Weiss's viewpoint, things were not going well at all. She was flabbergasted when told that her son, who was delusional and far from his normal self, suddenly was sufficiently competent to consent to a research trial. As she visited him over the ensuing weeks, she became convinced that whatever drug he was randomized to was simply not working, and that he needed a different treatment. She wrote numerous letters and protested in person to the Department of Psychiatry, which ignored her input totally. (It is pretty standard for psychiatrists, in my limited experience, to decide that the family members of psychiatric patients are either mentally disturbed themselves, or else are part of the environment that may have caused the psychiatric disorder in the patient, leading them to view the family member more as an enemy than an ally in therapy.) On May 8, 2004, Dan Markingson killed himself by mutilating his own body with a knife, leaving a note behind, "I went through this experience smiling!"
Dr. Olson and his colleagues expressed regret but not surprise that such a severely disturbed patient should have committed suicide, and noted that the research study could not have caused the death, as the three drugs were all in common use and in almost all circumstances, Dr. Olson would have started Dan on one of those three drugs, trial or no trial. In theory the research trial was to Dan's advantage because it assured closer monitoring. From Mary's point of view, Dan had been effectively coerced into the trial, being told that he'd be committed again unless he consented, and was unable at that point in time to make rational decisions about enrollment or nonenrollment. While the trial did not perhaps dictate the initial treatment, it certainly became a factor in keeping Dan on a treatment for many months while (as per Mary) his symptoms actually were worsening, as the University stood to lose their funding if he had been taken off the study drug.
The next to last chapter was that Mary Weiss sued the University and Dr. Olson. The court threw out the suit against the University arguing statutory immunity for a state institution. She collected, she said, $75,000 in a settlement with Dr. Olson which only went to pay her outstanding legal bills.
The last chapter is an especially sad commentary on the University as poor citizen of the community. Having gotten off the hook via statutory immunity, we would have expected the University to declare victory and retire from the field. Instead the U. took the unusual step of countersuing Mary Weiss to collect $57,000, which it claimed were its own legal fees in defending against her suit. Mary had no money to defend herself against the countersuit. She was forced to reach a settlement with Minnesota, one provision of which was to promise not to appeal her original ruling.
What are we to make of this countersuit? In HOOKED I discuss the phemonenon of SLAPP, "strategic lawsuit against public participation." A SLAPP happens when a powerful party with deep pockets but with a very weak legal position sues a citizen who's making noise about the issue in a way that's uncomfortable for the powerful party. The suit may have no real legal merit and is almost sure to lose when and if it comes before a judge. But the weaker party has no financial ability to pursue the lawsuit to its conclusion, and is forced to settle as quickly as possible. This usually is a strategy for sending a chilling message to anyone bold enough to criticize the powerful party--don't do it, says the message, or you may just find yourself entangled in a lawsuit from which it will take all of your money to extricate yourself. In this specific case, the purpose of SLAPP might have been to prevent an appeal that the University feared it would lose, especially if the behavior of Dr. Olson was viewed in light of the financial conflicts of interest.
Sunday, April 4, 2010
CNN: Pfizer Too Big to Prosecute; Shadow Company Takes the Hit
A bit of ancient history: As I described in HOOKED, Australian business sociologist John Braithwaite, in the course of doing the research for his 1984 book, Corporate Crime in the Pharmaceutical Industry, was interested to discover that more than one U.S. drug firm had a position in the organizational chart informally called "vice president in charge of going to jail." The lines of authority were arranged so that, if the firm was ever caught doing illegal things, this particular VP would take the hit and thereby protect higher-ups from criminal prosecution; and that VP's compensation package included appropriate recompense for this service. This handy arrangement was later messed up by a U.S. Supreme Court ruling in a case called Park. According to Park, I gather, the court held that if a company did wrong, and somebody had to be blamed, it had to go up to the CEO. So the position of "VP in charge of going to jail" presumably went the way of the dinosaurs and the dodo.
Now fast forward to the present. According to a CNN special report:
http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/?hpt=Sbin
--the old VP in charge of going to jail has been replaced with the shell company in charge of being prosecuted for the main firm's misdeeds. This is a much nicer arrangement as there really is no shell company, so no one has to go to jail, or to be paid extra for running the risk.
A number of media sources have been discussing the recent settlement between US Federal prosecutors and Pfizer over the off-label marketing of Bextra. (See my previous post on that topic, http://brodyhooked.blogspot.com/search?q=bextra.) The angle that most of the media have explored is that the actual amount of money paid out by Pfizer in fines and lawsuits, even though it tops $2B, is so far short of the profits the company made from Bextra sales as to be a mere pittance. (CNN calculates that Pfizer has so far paid out the equivalent of three months' worth of profits for a drug that was on the market for several years.) The documented fact that Pfizer was engaged in this illegal off-label marketing of Bextra at the same time as it was pleading guilty to earlier instances of illegal off-label marketing, and promising up, down, and sideways that it had learned its lesson and would never do those terrible things again, shows that for the big companies, these fines are nothing more or less than a cost of doing business and therefore fail to serve as any form of deterrent against future wrongdoing.
CNN chose to shine its spotlight on a somewhat different angle. As I covered in the previous post, the basic Federal problem in prosecuting Pfizer was that it is "too big to jail" in much the same sense that the global banking giants are "too big to fail." The law requires that if Pfizer were to be successfully prosecuted for criminal offenses, it would be immediately banned from doing any business with either Medicare or Medicaid. This would have two consequences. First, a large number of patients who now depend on Pfizer drugs, including some brand name products for which there is no generic substitute, would be unable to get their medicines. Those people and their physicians could be expected to set up an immediate howl that would quickly be heard in the halls of Congress. Second, unable to sell to such huge markets, Pfizer would probably go bust. That would lead to the unemployment of thousands of company employees, most of whom had nothing to do with illegal marketing, in the middle of a severe recession, and the resulting howl would be heard immediately in the halls of Congress.
What to do? The creative Feds have successfully prosecuted a company for Pfizer's misdeeds. That company freely admitted its guilt and as a result is now banned from selling any drugs to Medicare or Medicaid. The company is called Pharmacia & Upjohn Co., Inc. Old-timers might recall that both Upjohn and Pharmacia are former drug firms that were bought out by Pfizer and thereupon ceased to exist as independent firms. Pharmacia & Upjohn Co., Inc. has no assets or employees and manufactures no drugs. It exists only as an on-paper shell company, totally owned by Pfizer. It was actually invented back in 2007 by Pfizer for the same purpose, to take the hit for an earlier prosecution. Since it happened to still be around, on paper, it was the best target to take the hit for this latest offense as well.
As I reviewed in that earlier post, Ann Woolner wrote in Business Week that nothing today prevents the Feds from prosecuting a drug firm and its executives under misdemeanor instead of felony charges. You can throw somebody in jail for certain misdemeanors. If you want to send a message to drug companies that they cannot get away with illegal behavior, while avoiding the serious consequences of a company like Pfizer actually going out of business, the best way to do this (says Woolner) is to charge some of their top executives with misdemeanors and throw them in the slammer for 6 months or whatever the law allows. What we would now have to guard against is these execs setting up shell companies of themselves and telling the Feds to put that shell company into jail instead of them. I guess when you have that kind of bankroll to hire the country's smartest lawyers, anything is possible.
Now fast forward to the present. According to a CNN special report:
http://www.cnn.com/2010/HEALTH/04/02/pfizer.bextra/?hpt=Sbin
--the old VP in charge of going to jail has been replaced with the shell company in charge of being prosecuted for the main firm's misdeeds. This is a much nicer arrangement as there really is no shell company, so no one has to go to jail, or to be paid extra for running the risk.
A number of media sources have been discussing the recent settlement between US Federal prosecutors and Pfizer over the off-label marketing of Bextra. (See my previous post on that topic, http://brodyhooked.blogspot.com/search?q=bextra.) The angle that most of the media have explored is that the actual amount of money paid out by Pfizer in fines and lawsuits, even though it tops $2B, is so far short of the profits the company made from Bextra sales as to be a mere pittance. (CNN calculates that Pfizer has so far paid out the equivalent of three months' worth of profits for a drug that was on the market for several years.) The documented fact that Pfizer was engaged in this illegal off-label marketing of Bextra at the same time as it was pleading guilty to earlier instances of illegal off-label marketing, and promising up, down, and sideways that it had learned its lesson and would never do those terrible things again, shows that for the big companies, these fines are nothing more or less than a cost of doing business and therefore fail to serve as any form of deterrent against future wrongdoing.
CNN chose to shine its spotlight on a somewhat different angle. As I covered in the previous post, the basic Federal problem in prosecuting Pfizer was that it is "too big to jail" in much the same sense that the global banking giants are "too big to fail." The law requires that if Pfizer were to be successfully prosecuted for criminal offenses, it would be immediately banned from doing any business with either Medicare or Medicaid. This would have two consequences. First, a large number of patients who now depend on Pfizer drugs, including some brand name products for which there is no generic substitute, would be unable to get their medicines. Those people and their physicians could be expected to set up an immediate howl that would quickly be heard in the halls of Congress. Second, unable to sell to such huge markets, Pfizer would probably go bust. That would lead to the unemployment of thousands of company employees, most of whom had nothing to do with illegal marketing, in the middle of a severe recession, and the resulting howl would be heard immediately in the halls of Congress.
What to do? The creative Feds have successfully prosecuted a company for Pfizer's misdeeds. That company freely admitted its guilt and as a result is now banned from selling any drugs to Medicare or Medicaid. The company is called Pharmacia & Upjohn Co., Inc. Old-timers might recall that both Upjohn and Pharmacia are former drug firms that were bought out by Pfizer and thereupon ceased to exist as independent firms. Pharmacia & Upjohn Co., Inc. has no assets or employees and manufactures no drugs. It exists only as an on-paper shell company, totally owned by Pfizer. It was actually invented back in 2007 by Pfizer for the same purpose, to take the hit for an earlier prosecution. Since it happened to still be around, on paper, it was the best target to take the hit for this latest offense as well.
As I reviewed in that earlier post, Ann Woolner wrote in Business Week that nothing today prevents the Feds from prosecuting a drug firm and its executives under misdemeanor instead of felony charges. You can throw somebody in jail for certain misdemeanors. If you want to send a message to drug companies that they cannot get away with illegal behavior, while avoiding the serious consequences of a company like Pfizer actually going out of business, the best way to do this (says Woolner) is to charge some of their top executives with misdemeanors and throw them in the slammer for 6 months or whatever the law allows. What we would now have to guard against is these execs setting up shell companies of themselves and telling the Feds to put that shell company into jail instead of them. I guess when you have that kind of bankroll to hire the country's smartest lawyers, anything is possible.
Friday, April 2, 2010
Pharma and the Gumshoes, Revisited
This post might best fit in the You Can't Make This Sort of Stuff Up category, but I'll try at the end to draw a meaningful lesson from it.
Eamon Javers at Politico recently revealed:
http://www.politico.com/news/stories/0310/35212.html
--that Amphastar Pharmaceuticals, Inc. paid more than $100,000 to a private investigation agency, Kroll, to snoop on Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research, and on Moheb Nasr, director of the FDA's Office of New Drug Quality Assessment. Turns out that Amphastar was suspicious because the FDA seemed to be dragging its feet in approving its generic-drug application for a low-molecular-weight heparin (anti-clotting drug). The company decided that maybe the FDA was favoring its rival company, Momenta Pharmaceuticals, and so set out to see whether Woodcock and Nasr had any ties to Momenta. They were especially suspicious because Woodcock and one of the co-founders of Momenta had appeared together on a program in Thailand in 2007.
In the end nothing suggestive of inappropriate ties or influence surfaced. One has to wonder about just what Amphastar got for its $100K. According to Javers's article, among the facts Kroll unearthed about Woodcock were her birthdate, the state in which her Social Security number had been issued, who her husband was, and the value of their home. Brilliant detective work, that.
Amphastar's general counsel protested "there was no impropriety" in its hiring Kroll and going after Woodcock and Nasr in this way. Sen. Max Baucus denounced the matter as "an outrage" and added, “Pharmaceutical companies should be focusing on getting their drugs approved based on health research and science rather than wasting their resources hiring private investigators to snoop around the lives of FDA regulators and their families.”
Much as I approve of Sen. Baucus's additional sentiments, I find his denunciation of Amphastar somewhat naive. After all, drug companies have observed how easy it is to wave around a wad of cash, and have academic physicians swarming around like flies on garbage, eager to grab their share in exchange for doing whatever the company wants. The companies figure that if it works for them, their competitors must be doing it too. From those observations it's a short jump to conclude that if people as high up on and social-respect ladder as academic physicians act like that, then FDA officials must, too. So this is simply a matter of rational calculation on Amphastar's part--except, perhaps, for the detective firm they hired. (Just kidding, Kroll folks; please don't start going through my trash.)
PS: If anyone wonders what the history is of drug firms hiring private eyes, read HOOKED on the Betty Dong case in which the pharmaceutical company used private investigators to try to discredit an academic investigator who got results the company didn't like. Or for a more colorful read, go to John Le Carre's novel, The Constant Gardener.
Eamon Javers at Politico recently revealed:
http://www.politico.com/news/stories/0310/35212.html
--that Amphastar Pharmaceuticals, Inc. paid more than $100,000 to a private investigation agency, Kroll, to snoop on Janet Woodcock, Director of the FDA's Center for Drug Evaluation and Research, and on Moheb Nasr, director of the FDA's Office of New Drug Quality Assessment. Turns out that Amphastar was suspicious because the FDA seemed to be dragging its feet in approving its generic-drug application for a low-molecular-weight heparin (anti-clotting drug). The company decided that maybe the FDA was favoring its rival company, Momenta Pharmaceuticals, and so set out to see whether Woodcock and Nasr had any ties to Momenta. They were especially suspicious because Woodcock and one of the co-founders of Momenta had appeared together on a program in Thailand in 2007.
In the end nothing suggestive of inappropriate ties or influence surfaced. One has to wonder about just what Amphastar got for its $100K. According to Javers's article, among the facts Kroll unearthed about Woodcock were her birthdate, the state in which her Social Security number had been issued, who her husband was, and the value of their home. Brilliant detective work, that.
Amphastar's general counsel protested "there was no impropriety" in its hiring Kroll and going after Woodcock and Nasr in this way. Sen. Max Baucus denounced the matter as "an outrage" and added, “Pharmaceutical companies should be focusing on getting their drugs approved based on health research and science rather than wasting their resources hiring private investigators to snoop around the lives of FDA regulators and their families.”
Much as I approve of Sen. Baucus's additional sentiments, I find his denunciation of Amphastar somewhat naive. After all, drug companies have observed how easy it is to wave around a wad of cash, and have academic physicians swarming around like flies on garbage, eager to grab their share in exchange for doing whatever the company wants. The companies figure that if it works for them, their competitors must be doing it too. From those observations it's a short jump to conclude that if people as high up on and social-respect ladder as academic physicians act like that, then FDA officials must, too. So this is simply a matter of rational calculation on Amphastar's part--except, perhaps, for the detective firm they hired. (Just kidding, Kroll folks; please don't start going through my trash.)
PS: If anyone wonders what the history is of drug firms hiring private eyes, read HOOKED on the Betty Dong case in which the pharmaceutical company used private investigators to try to discredit an academic investigator who got results the company didn't like. Or for a more colorful read, go to John Le Carre's novel, The Constant Gardener.
Thursday, March 25, 2010
More on Strict Measures Proposed in India
Pharmascolds in the U.S. are celebrating the passage of the Physician Payment Sunshine Law, which (viewed cynically) allows all docs to take as much money as they want from Pharma, only they have to disclose it. It is breathtaking to see how far the U.S. scene lags behind India if this news account is indicative (open source; hat tip to Healthy Skepticism listserv for making me aware of it):
http://www.pharmabiz.com/article/detnews.asp?articleid=54670§ionid=
MCI asks Health Ministry to make pharma cos punishable for gifting docs
Thursday, March 25, 2010 08:00 IST Ramesh Shankar, Mumbai
The Medical Council of India (MCI) has asked the Union Health Ministry to amend the Drugs and Cosmetics Act to bring the pharmaceutical companies under the ambit of the law in making them punishable for rolling out freebies to the doctors for promoting their medicines. At present, only the doctors who accept gifts from companies will invite action by the MCI, and the pharma companies who roll out the gifts are out of the purview of the law.
MCI chairman Dr Ketan Desai said that the MCI has written a letter to the union health ministry in this regard. He said the MCI has suggested the cancellation of licenses of such pharma companies who are found to be involved in unethical trade practices.
Coming close on the heels of its recent notification under which the doctors who accept any kind of gifts from pharma companies will invite cancellation of their registration to practice, the MCI's new initiative will bring the pharma companies under the law in which they will be punished if found guilty of giving any kind of gift to the doctors as part of their promotional activity. The pharma companies very often extend several kinds of gifts to the doctors including domestic and foreign holiday packages to promote their products. The MCI's initiative to make the pharma companies also legally bound to follow the ethical trade practices comes in the wake of media reports that several pharma companies are still openly floundering norms to offer gifts to the doctors to promote their medicines. Recently there were reports in the media that prominent pharma companies like Dr Reddy's and Piramal had resorted to unethical trade practices. While, Piramal had taken a group of doctors to Turkey, Dr Reddy's had taken the doctors to Hyderabad for some seminars. There are reports that several other companies are also resorting to the same practice, giving scant to regard to the MCI's notification that restraints doctors from accepting gifts.
Like accepting a gift, giving a gift is also equally wrong. At present, we cannot take any action against the pharma companies for giving gifts to the doctors. So, we sought an amendment in the Drugs and Cosmetics Act to bring the pharmaceutical companies under the ambit of the law in making them punishable for rolling out freebies to the doctors for promoting their medicines, Dr Desai said.
He said that the MCI has asked the Drug Controller General of India (DCGI) to ask the pharma companies to restrain from such unethical trade practices.
Dr Desai also said that even though the MCI had written letters to the doctors and the pharma companies involved in the recent controversy, they did not respond to the MCI so far.
So-- the folks who function for India as equivalent to state medical licensing boards in the US, if I get the picture, have already told docs they may lose their licenses if they take any stuff at all from drug companies--and now want the law to prohibit the companies from offering the stuff in the first place.
I have suggested in my initial comment that India is "ahead" of the US in this area, and I believe that to be so in recognizing the depth of the problem. But I did not mean that as to suggest that I personally favor a criminalizing solution to the problem. I have from the get-go tried to argue that this is a matter of medical profesisonalism, and the integrity of medical practitioners, rather than legal penalties, would ideally govern. That of course requires that we medical folk hurry up and develop some integrity!
http://www.pharmabiz.com/article/detnews.asp?articleid=54670§ionid=
MCI asks Health Ministry to make pharma cos punishable for gifting docs
Thursday, March 25, 2010 08:00 IST Ramesh Shankar, Mumbai
The Medical Council of India (MCI) has asked the Union Health Ministry to amend the Drugs and Cosmetics Act to bring the pharmaceutical companies under the ambit of the law in making them punishable for rolling out freebies to the doctors for promoting their medicines. At present, only the doctors who accept gifts from companies will invite action by the MCI, and the pharma companies who roll out the gifts are out of the purview of the law.
MCI chairman Dr Ketan Desai said that the MCI has written a letter to the union health ministry in this regard. He said the MCI has suggested the cancellation of licenses of such pharma companies who are found to be involved in unethical trade practices.
Coming close on the heels of its recent notification under which the doctors who accept any kind of gifts from pharma companies will invite cancellation of their registration to practice, the MCI's new initiative will bring the pharma companies under the law in which they will be punished if found guilty of giving any kind of gift to the doctors as part of their promotional activity. The pharma companies very often extend several kinds of gifts to the doctors including domestic and foreign holiday packages to promote their products. The MCI's initiative to make the pharma companies also legally bound to follow the ethical trade practices comes in the wake of media reports that several pharma companies are still openly floundering norms to offer gifts to the doctors to promote their medicines. Recently there were reports in the media that prominent pharma companies like Dr Reddy's and Piramal had resorted to unethical trade practices. While, Piramal had taken a group of doctors to Turkey, Dr Reddy's had taken the doctors to Hyderabad for some seminars. There are reports that several other companies are also resorting to the same practice, giving scant to regard to the MCI's notification that restraints doctors from accepting gifts.
Like accepting a gift, giving a gift is also equally wrong. At present, we cannot take any action against the pharma companies for giving gifts to the doctors. So, we sought an amendment in the Drugs and Cosmetics Act to bring the pharmaceutical companies under the ambit of the law in making them punishable for rolling out freebies to the doctors for promoting their medicines, Dr Desai said.
He said that the MCI has asked the Drug Controller General of India (DCGI) to ask the pharma companies to restrain from such unethical trade practices.
Dr Desai also said that even though the MCI had written letters to the doctors and the pharma companies involved in the recent controversy, they did not respond to the MCI so far.
So-- the folks who function for India as equivalent to state medical licensing boards in the US, if I get the picture, have already told docs they may lose their licenses if they take any stuff at all from drug companies--and now want the law to prohibit the companies from offering the stuff in the first place.
I have suggested in my initial comment that India is "ahead" of the US in this area, and I believe that to be so in recognizing the depth of the problem. But I did not mean that as to suggest that I personally favor a criminalizing solution to the problem. I have from the get-go tried to argue that this is a matter of medical profesisonalism, and the integrity of medical practitioners, rather than legal penalties, would ideally govern. That of course requires that we medical folk hurry up and develop some integrity!
Wednesday, March 24, 2010
NIMH Director on Industry Influence over Psychiatry
The current JAMA (subscription required) features a commentary by Dr. Thomas R. Insel, Director of the National Institutes of Mental Health, on the problem of Pharma influence over psychiatry. Our blogging friends have quite different takes on the matter.
To Barney Carroll--
http://hcrenewal.blogspot.com/2010/03/dr-pangloss-as-nih-institute-director.html
--Dr. Insel has participated in a whitewash, spending most of the commentary making excuses that psychiatrists are at the pharmaceutical industry trough about the same amount as the pigs from other medical specialties, so it is unfair to single them out. Dr. Carroll opines that this whitewash may be motivated by Dr. Insel's close ties with Dr. Charles Nemeroff, whose escapades we have detailed on numerous occasions and is basically the poster child for academic psychiatrists eagerly doing the bidding of industry. Dr. Insel alludes elliptically to "the resignation of a chair of a prestigious psychiatry department" as one of the "major effects" produced by heightened publicity around conflicts of interest in his field. (Nemeroff, as we have covered, resigned as chair at Emory but soon after was hired on as chair by Miami.)
To Danny Carlat--
http://carlatpsychiatry.blogspot.com/2010/03/dr-tom-insel-nimh-chief-scolds.html
--it is much more significant that Dr. Insel has severely scolded his fellow psychiatrists in a national medical forum. Just to add a bit of fuel to the debate, the first comment on Dr. Carlat's blog posting is from Dr. Insel himself, who disputes many of Dr. Carroll's facts regarding the close ties Insel allegedly had with Dr. Nemeroff.
So I read the Commentary in JAMA carefully to try to figure out whom I agreed with, and find myself in this instance backing Dr. Carlat's general take on the matter. I can see how Drs. Carroll and Carlat came to such different conclusions because the Commentary is strangely composed, and actually seems to be two commentaries published side by side. One, as Dr. Carroll states, is largely a defense of psychiatry against charges that its practitioners are of lower moral caliber than other specialists. The second, as Dr. Carlat correctly points out, is an attack on his specialty for allowing industry money to distract it from science and quality patient care. Dr. Insel focuses mostly on the many non-drug treatments for mental illness, which have been scientifically proven, and yet remain largely underused and in some cases unreimbursed due to psychiatry's love affair with medications.
Perhaps Dr. Insel made a calculation that he needed to include his first commentary, making excuses for psychiatrists, as a sort of sugar coating on the bitterer pill of his second commentary. If so, he may have miscalculated as mostly he just confuses the reader as to what his main point is. I'll hope that the "real" Dr. Insel is the guy who wrote: "[A]cademic leaders and their professional societies will need to transform what has become a culture of influence. The greatest threat to an era of improved public health stemming from the productive and ethically sound relationship among academia, industry, and practice is a defiant embrace of the status quo..."
Insel TR. Psychiatrists' relationships with pharmaceutical companies: part of the problem or part of the solution? [commentary] JAMA 303:1192-93, Mar. 24/31, 2010.
To Barney Carroll--
http://hcrenewal.blogspot.com/2010/03/dr-pangloss-as-nih-institute-director.html
--Dr. Insel has participated in a whitewash, spending most of the commentary making excuses that psychiatrists are at the pharmaceutical industry trough about the same amount as the pigs from other medical specialties, so it is unfair to single them out. Dr. Carroll opines that this whitewash may be motivated by Dr. Insel's close ties with Dr. Charles Nemeroff, whose escapades we have detailed on numerous occasions and is basically the poster child for academic psychiatrists eagerly doing the bidding of industry. Dr. Insel alludes elliptically to "the resignation of a chair of a prestigious psychiatry department" as one of the "major effects" produced by heightened publicity around conflicts of interest in his field. (Nemeroff, as we have covered, resigned as chair at Emory but soon after was hired on as chair by Miami.)
To Danny Carlat--
http://carlatpsychiatry.blogspot.com/2010/03/dr-tom-insel-nimh-chief-scolds.html
--it is much more significant that Dr. Insel has severely scolded his fellow psychiatrists in a national medical forum. Just to add a bit of fuel to the debate, the first comment on Dr. Carlat's blog posting is from Dr. Insel himself, who disputes many of Dr. Carroll's facts regarding the close ties Insel allegedly had with Dr. Nemeroff.
So I read the Commentary in JAMA carefully to try to figure out whom I agreed with, and find myself in this instance backing Dr. Carlat's general take on the matter. I can see how Drs. Carroll and Carlat came to such different conclusions because the Commentary is strangely composed, and actually seems to be two commentaries published side by side. One, as Dr. Carroll states, is largely a defense of psychiatry against charges that its practitioners are of lower moral caliber than other specialists. The second, as Dr. Carlat correctly points out, is an attack on his specialty for allowing industry money to distract it from science and quality patient care. Dr. Insel focuses mostly on the many non-drug treatments for mental illness, which have been scientifically proven, and yet remain largely underused and in some cases unreimbursed due to psychiatry's love affair with medications.
Perhaps Dr. Insel made a calculation that he needed to include his first commentary, making excuses for psychiatrists, as a sort of sugar coating on the bitterer pill of his second commentary. If so, he may have miscalculated as mostly he just confuses the reader as to what his main point is. I'll hope that the "real" Dr. Insel is the guy who wrote: "[A]cademic leaders and their professional societies will need to transform what has become a culture of influence. The greatest threat to an era of improved public health stemming from the productive and ethically sound relationship among academia, industry, and practice is a defiant embrace of the status quo..."
Insel TR. Psychiatrists' relationships with pharmaceutical companies: part of the problem or part of the solution? [commentary] JAMA 303:1192-93, Mar. 24/31, 2010.
Subscribe to:
Posts (Atom)