I had some nice conversations earlier this week with a couple of reporters for the Dallas Morning News, around this latest investigative reporting venture from ProPublica:
http://www.propublica.org/article/pharma-payments-to-doctors-with-sanctions
Earlier, ProPublica had announced their "Dollars for Docs" database of physicians receiving drug company payments (http://projects.propublica.org/docdollars/), and had done some initial reporting about what these figures showed in collaboration with several major newspapers:
http://brodyhooked.blogspot.com/2010/10/from-propublica-seamy-side-of-pharma.html
This latest dip into the seamy world of physician bribes from Pharma has focused on a simple recipe: first get the database of docs getting money from the drug industry, then access the public databases showing physicians who have been disciplined by their state licensing boards, and stir. The result was that after they had eliminated the minor infractions that seemed not to implicate the physicians' quality of patient care, some 290 names showed up on both lists--and 70 names indicated multiple disciplinary actions.
Two physicians were interviewed in the ProPublica article linked to above, and each denied any wrongdoing that actually affected patient care. And I think fairness requires the acknowledgement that there are times when an innocent physician is being unfairly accused before the licensing board, and the sheer time and expense of fighting to clear one's name leads to the prudent decision to accept a plea-bargain agreement (I am familiar with several physicians railroaded into such a situation when their only "offense" was prescribing adequate opiates for patients with severe chronic pain. I was also told that if one wishes to fight an unfair ruling of the Texas Medical Board in court, plan to spend at least a quarter of a million dollars.)
It would have been nice if ProPublica had told us what percentage of the docs in their database this 290 makes up-- is it 20% or 2%?
All that said, there are a couple of important implications of this finding. First, I hope that once again these data will put a nail in the coffin of the idea of "Key opinion leaders." The industry has always claimed that the reason it paid big bucks to Doc X is that Doc X is the most talented and knowledgeable guy on this particular disease on the planet. This in turn has led others like the FDA (before the new leadership took over) to claim that if they tried to exclude docs with financial conflicts of interest from review panels, guideline committees, etc. they would lose the input of the best and the brightest. If it turns out that the folks selected for these payments/bribes actually include a fair number of medicine's bottom feeders, then we can see even more clearly that these bribes are nothing but rewards for high prescribing and have nothing whatever to do with the talents and knowledge of the recipients.
Another great point was made in the ProPublica piece by my bioethicist colleage Josephine Johnston at the Hastings Center. She points out that when you are sitting on the fat bankrolls of the major drug firms, you can afford to do most anything you want--including prescreening docs for licensing violations before you sign them up. The fact that the industry never bothered to do this is therefore somewhat telling.
ProPublica obviously struck a nerve. As the article notes, at least four major drug firms, on being interviewed for the piece, said that they would immediately review their procedures to see why these physicians had been signed up and consider better screening in the future.
And, no matter what the content, it is sort of nice to see that investigative reporting by newspapers has not completely died out.
Thursday, November 18, 2010
Wednesday, November 17, 2010
Electronic Records: Somebody's Listening
In previous posts--
http://brodyhooked.blogspot.com/2010/09/more-on-ehrs-and-safety.html
http://brodyhooked.blogspot.com/2010/08/are-electronic-health-records-medical.html
--I looked over at the field of health information technology to see if there were parallels with some of the issues we face in connection with pharmaceuticals. The initial reports were worrisome. After notable success with the first generation of "home grown" electrionic health records (EHRs), software firms saw a market for off-the-shelf records systems that they could peddle to hospitals and doctors' offices. In the process they often failed to debug the system or to address the criticial software-user interface issues, so that we began to hear increased reports of patient harm or risk resulting from the implementation of flawed EHR products. Yet the politicians continued to extol the EHR as if it could do no wrong and would solve all the cost and quality problems in health care. The Obama Administration seems poised to pour billions into EHRs with minimal attention to quality control.
Hence I was delighted to see an e-mail from my esteemed Michigan colleague and EHR expert, Dr. Scott Monteith:
"I’m in DC at the American Medical Informatics Association (AMIA) meeting... [S]uffice [it] to say that the medical informaticists/HIT experts are tempering their enthusiasm for HIT, with many questioning ... HIT safety/efficacy, etc ... For example, there was a standing-room-only debate addressing this question: are EHRs safe and effective? After the debate the audience of largely medical informaticists voted NO, they are not. "
Dr. Monteith here describes an important shift in opinion. Most of the physicians who became "early adopters" of EHRs were passionate about the potential advantages and initially were very reluctant to voice any concerns. The few who became the pioneer nay-sayers were often treated as outcasts. Yet now the concerns are fast becoming mainstream.
My personal story is that during the last 5 years I was actively seeing patients, 2001-2006, my academic family practice group used an electronic record that we researched carefully before purchasing. Our experience was overall highly positive, and I came away quite enamored of the advantages of EHRs and was a bit slow on the uptake to recognize the downside. So I am far from being an opponent of the EHR myself. But, to repeat my previously posted comment, a software company that starts to sell EHRs must acknowledge that it just became a medical device manufacturer, and whatever the ethics are of selling software to take the redeye out of your home snapshots, medical devices are a different matter entirely and the responsibility for safety and quality just went up by a factor of 10 or 100. Fortunately at least the docs heavily involved with HIT/EHRs are starting to get this message.
http://brodyhooked.blogspot.com/2010/09/more-on-ehrs-and-safety.html
http://brodyhooked.blogspot.com/2010/08/are-electronic-health-records-medical.html
--I looked over at the field of health information technology to see if there were parallels with some of the issues we face in connection with pharmaceuticals. The initial reports were worrisome. After notable success with the first generation of "home grown" electrionic health records (EHRs), software firms saw a market for off-the-shelf records systems that they could peddle to hospitals and doctors' offices. In the process they often failed to debug the system or to address the criticial software-user interface issues, so that we began to hear increased reports of patient harm or risk resulting from the implementation of flawed EHR products. Yet the politicians continued to extol the EHR as if it could do no wrong and would solve all the cost and quality problems in health care. The Obama Administration seems poised to pour billions into EHRs with minimal attention to quality control.
Hence I was delighted to see an e-mail from my esteemed Michigan colleague and EHR expert, Dr. Scott Monteith:
"I’m in DC at the American Medical Informatics Association (AMIA) meeting... [S]uffice [it] to say that the medical informaticists/HIT experts are tempering their enthusiasm for HIT, with many questioning ... HIT safety/efficacy, etc ... For example, there was a standing-room-only debate addressing this question: are EHRs safe and effective? After the debate the audience of largely medical informaticists voted NO, they are not. "
Dr. Monteith here describes an important shift in opinion. Most of the physicians who became "early adopters" of EHRs were passionate about the potential advantages and initially were very reluctant to voice any concerns. The few who became the pioneer nay-sayers were often treated as outcasts. Yet now the concerns are fast becoming mainstream.
My personal story is that during the last 5 years I was actively seeing patients, 2001-2006, my academic family practice group used an electronic record that we researched carefully before purchasing. Our experience was overall highly positive, and I came away quite enamored of the advantages of EHRs and was a bit slow on the uptake to recognize the downside. So I am far from being an opponent of the EHR myself. But, to repeat my previously posted comment, a software company that starts to sell EHRs must acknowledge that it just became a medical device manufacturer, and whatever the ethics are of selling software to take the redeye out of your home snapshots, medical devices are a different matter entirely and the responsibility for safety and quality just went up by a factor of 10 or 100. Fortunately at least the docs heavily involved with HIT/EHRs are starting to get this message.
Tuesday, November 16, 2010
Pfizer's Reboxetine: Latest in a Series of Suppression of Unfavorable Data
Last month, a team from IGWIG, an independent, non-governmental body created in Germany to do health technology assessment, published a pair of papers in BMJ:
http://www.bmj.com/content/341/bmj.c4737.full
http://www.bmj.com/content/341/bmj.c4942.full
The main article was a meta-analysis of the antidepressant, reboxetine, manufactured by Pfizer. This drug, a newer generation antidepressant that selectively inhibits norepinephrine reuptake rather than serotonin, has been approved for sale in several European countries, but was rejected by the US FDA. Published meta-analyses showed that the drug was modestly effective, and perhaps about the same in both efficacy and safety as other popular antidepressants.
Somehow the IGWIG folks were able to figure out that the published trials did not embrace the total number of subjects actually enrolled in research studies. Their initial assessment of the drug was that due to missing data, they could not issue a recommendation. Initially Pfizer complained about this, but then changed tack and for some reason, actually disclosed all their in-house data to the IGWIG people. Based on that new body of data, the IGWIG team performed a new meta-analysis, which BMJ published. (The second article describes the process by which IGWIG secured the data.)
The new meta-analysis reveals that although nearly 4600 subjects were enrolled in trials of reboxetine (comparing it to either placebo or SSRI antidepressants), the published data on which previous meta-analyses relied included only about 1/4 of those. If the totality of the data are reviewed, the IGWIG team concluded: "Reboxetine is, overall, an ineffective and potentially harmful antidepressant."
If you bother to look at the BMJ paper's figures, you'll see the graphic presentations of the various trials of the drug, either for drug efficacy or for side effects and safety. Each plot shows what would appear to be clear publication bias. If Pfizer had reviewed all the studies, and had elected to publish out of about 13 studies the 1 or 2 studies that were most favorable to reboxetine, then the resulting plots would have been exactly what you see in the IGWIG meta-analysis.
BMJ accompanied the two IGWIG papers with an editorial:
http://www.bmj.com/content/341/bmj.c5641.full
--in which they said, "Lost in the sometimes rancorous debate over research transparency, and the reasons for publication and non-publication, is the most important thing: efforts are needed to restore trust in existing evidence. To that end, the BMJ is more interested in constructive use of data than finger pointing or blame. " They promised to publish a special theme issue late in 2011 on the problem of research publication transparency and offered to print any useful suggestions for reforming the present system, which as seems obvious is simply broken beyond repair.
For a while, it seemed our salvation was going to lie with trial registries. Just force the companies to register trials when they start, and it will become very har for them to pretend the trial did not exist if they later don't like the outcome. That was a hope that seemed alive when I wrote HOOKED. It now seems, sadly, that registries are not the sole answer, at a minimum. One problem is that registries don't seem to talk to each other very well so that the lack of a single, unified registry is becoming problematic. The second problem is that there are a lot of things the industry can do to the raw data that never show up in any registry--such as happened with the VIGOR trial, for instance, in which reportedly, just enough deaths that were probably due to heart attacks were reclassified as due to something else so as to make Vioxx seem safer than it was.
But as a small bright spot, something apparently worked--since in the US, the FDA never approved reboxetine.
http://www.bmj.com/content/341/bmj.c4737.full
http://www.bmj.com/content/341/bmj.c4942.full
The main article was a meta-analysis of the antidepressant, reboxetine, manufactured by Pfizer. This drug, a newer generation antidepressant that selectively inhibits norepinephrine reuptake rather than serotonin, has been approved for sale in several European countries, but was rejected by the US FDA. Published meta-analyses showed that the drug was modestly effective, and perhaps about the same in both efficacy and safety as other popular antidepressants.
Somehow the IGWIG folks were able to figure out that the published trials did not embrace the total number of subjects actually enrolled in research studies. Their initial assessment of the drug was that due to missing data, they could not issue a recommendation. Initially Pfizer complained about this, but then changed tack and for some reason, actually disclosed all their in-house data to the IGWIG people. Based on that new body of data, the IGWIG team performed a new meta-analysis, which BMJ published. (The second article describes the process by which IGWIG secured the data.)
The new meta-analysis reveals that although nearly 4600 subjects were enrolled in trials of reboxetine (comparing it to either placebo or SSRI antidepressants), the published data on which previous meta-analyses relied included only about 1/4 of those. If the totality of the data are reviewed, the IGWIG team concluded: "Reboxetine is, overall, an ineffective and potentially harmful antidepressant."
If you bother to look at the BMJ paper's figures, you'll see the graphic presentations of the various trials of the drug, either for drug efficacy or for side effects and safety. Each plot shows what would appear to be clear publication bias. If Pfizer had reviewed all the studies, and had elected to publish out of about 13 studies the 1 or 2 studies that were most favorable to reboxetine, then the resulting plots would have been exactly what you see in the IGWIG meta-analysis.
BMJ accompanied the two IGWIG papers with an editorial:
http://www.bmj.com/content/341/bmj.c5641.full
--in which they said, "Lost in the sometimes rancorous debate over research transparency, and the reasons for publication and non-publication, is the most important thing: efforts are needed to restore trust in existing evidence. To that end, the BMJ is more interested in constructive use of data than finger pointing or blame. " They promised to publish a special theme issue late in 2011 on the problem of research publication transparency and offered to print any useful suggestions for reforming the present system, which as seems obvious is simply broken beyond repair.
For a while, it seemed our salvation was going to lie with trial registries. Just force the companies to register trials when they start, and it will become very har for them to pretend the trial did not exist if they later don't like the outcome. That was a hope that seemed alive when I wrote HOOKED. It now seems, sadly, that registries are not the sole answer, at a minimum. One problem is that registries don't seem to talk to each other very well so that the lack of a single, unified registry is becoming problematic. The second problem is that there are a lot of things the industry can do to the raw data that never show up in any registry--such as happened with the VIGOR trial, for instance, in which reportedly, just enough deaths that were probably due to heart attacks were reclassified as due to something else so as to make Vioxx seem safer than it was.
But as a small bright spot, something apparently worked--since in the US, the FDA never approved reboxetine.
Friday, November 12, 2010
Are Physicians Taking Fewer Bribes/Gifts from Industry?
The degree to which U.S. physicians are on the take from the drug industry decreased between 2004 and 2009, according to the repeat version of a major national survey.
Dr. Eric G. Campbell and colleagues were responsible for the survey published in 2007, that used 2004 data to show that 94% of American docs had some sorts of financial ties with the drug industry. Repeating the survey in 2009 (subscription needed to access), they found this had dropped to 84%.
There were similar drops in just about every category of "gift": drug samples fell from 78% to 63.8%; food and beverages from 83% to 70.6%; speakers bureau payments, 16% to 8.6%; consulting payments, 18% to 6.7%. In one area, the new PhRMA code of conduct may actually have nearly omitted one egregious sort of payola--tickets to cultural or sporting events fell from 7% to 1.3%.
The investigators noted specialty-specific differences in which of these categories fell the most. Overall, cardiologists remained most "on the take" of any specialty. The data also showed that physicians reporting financial ties to Pharma were less likely than physicians with no tie to report that they prescribed generic drugs instead of equivalent brand-name drugs.
The biggest weakness in this study, as the authors gamely noted, is that it's strictly self-report. Therefore the falling figures may reflect not actual behavior, but rather the fact that it's now less socially acceptable to admit taking bribes.
In sum, we have seen (and have reported in HOOKED and on this blog) a number of events occurring between 2004 and 2009 that tended in the direction of urging physicians to take a harder look at financial ties to the drug indutry and to take actions to limit those entanglements. The data would provide some suggestion that maybe a few docs are listening--and also that we have a long way yet to go.
Campbell EG, Gruen RL, Mountford J, et al. A national survey of physician-industry relationships. New England Journal of Medicine 356:1742-50, 2007.
Campbell EG, Rao SR, DesRoches, CM, et al. Physician professionalism and changes in physician-industry relationships from 2004 to 2009. Archives of Internal Medicine 170:1820-26, Nov. 8, 2010.
Dr. Eric G. Campbell and colleagues were responsible for the survey published in 2007, that used 2004 data to show that 94% of American docs had some sorts of financial ties with the drug industry. Repeating the survey in 2009 (subscription needed to access), they found this had dropped to 84%.
There were similar drops in just about every category of "gift": drug samples fell from 78% to 63.8%; food and beverages from 83% to 70.6%; speakers bureau payments, 16% to 8.6%; consulting payments, 18% to 6.7%. In one area, the new PhRMA code of conduct may actually have nearly omitted one egregious sort of payola--tickets to cultural or sporting events fell from 7% to 1.3%.
The investigators noted specialty-specific differences in which of these categories fell the most. Overall, cardiologists remained most "on the take" of any specialty. The data also showed that physicians reporting financial ties to Pharma were less likely than physicians with no tie to report that they prescribed generic drugs instead of equivalent brand-name drugs.
The biggest weakness in this study, as the authors gamely noted, is that it's strictly self-report. Therefore the falling figures may reflect not actual behavior, but rather the fact that it's now less socially acceptable to admit taking bribes.
In sum, we have seen (and have reported in HOOKED and on this blog) a number of events occurring between 2004 and 2009 that tended in the direction of urging physicians to take a harder look at financial ties to the drug indutry and to take actions to limit those entanglements. The data would provide some suggestion that maybe a few docs are listening--and also that we have a long way yet to go.
Campbell EG, Gruen RL, Mountford J, et al. A national survey of physician-industry relationships. New England Journal of Medicine 356:1742-50, 2007.
Campbell EG, Rao SR, DesRoches, CM, et al. Physician professionalism and changes in physician-industry relationships from 2004 to 2009. Archives of Internal Medicine 170:1820-26, Nov. 8, 2010.
Monday, November 8, 2010
Review Time: Rationalizations Doctors Tell about Pharma Money
Most of the time I try to keep this blog focused on new information. Still, perhaps once in a while it is valuable to do a review of issues that we've addressed in the past. It's worth keeping track of whether phenomena we described in previous years are still occurring. Also, who knows--an occasional new reader may show up here (perhaps having wandered in thinking this was Facebook) and need to be brought up to speed.
An opportunity to do a rationalization review is provided by this newspaper article by Bill Lascher for the Clark County (Washington) Columbian:
An opportunity to do a rationalization review is provided by this newspaper article by Bill Lascher for the Clark County (Washington) Columbian:
http://www.columbian.com/news/2010/nov/07/pharmaceutical-industry-doctors-Clark-County/
Now, how would I know what's being printed in the Clark County Columbian? Mr. Lascher phoned me and asked for an interview, after he followed up on the new ProPublica database (http://brodyhooked.blogspot.com/2010/10/propublica-launches-database-on-docs.html). Let me first comment on the part of the article that contains that interview. I am sure I was not misquoted and that I said the words that were reported. Yet I still have a sense that my context was distorted, as I come across in this article sounding much more accepting and blase about docs taking money from Pharma than any reader of this blog would be aware of. Anyway if I had the interview to do over again I would certainly approach it differently.That's merely by the way, however, as my main agenda here is to look at what Mr. Lascher found in his home county, and what the various players had to say about it. I'll report that in the form of "Quote" from the article and "Translation" into plain English, stripped of the usual rationalizations.
A good deal of the article discusses a certain Dr. Jeffrey J. Hansen, who topped out the local doc's money list at $107,302, about 5 times more than his nearest competitor. Here's what Dr. Hansen had to say about his take:
Quote: “I don’t believe it influences my prescribing practices because I work with a number of companies,” Hansen said. “I want to make sure that no matter who’s sponsoring my speaking the message is the same.”
Translation: Lots to discuss here. Does it influence his prescribing? The companies surely hope so. We've seen recently--http://brodyhooked.blogspot.com/2010/10/from-propublica-seamy-side-of-pharma.html--yet more evidence that being picked to be on a company's speakers' bureau is more about the volume of their stuff you prescribe and a lot less about your speaking abilities. Does it make a difference if he works for many companies? I wonder how often he recommends exercise instead of drugs for mild to moderate depression, or how often he talks about the body of research that suggests that the newer SSRI antidepressants are little better than placebo in large meta-analyses. Is the message the same? Very unlikely; most companies supply their speakers with the company PowerPoint and demand they stick with the script, since deviating from it could land the company in hot water with the Feds.
Quote: “When I partner with a pharmaceutical company they actually cover the cost of my overhead in presenting this data,” he said. “I enjoy the process of speaking and talking about psychiatry and I do think it improves quality of care for patients.”
Translation: Well, if $107K just barely covers his office overhead, then either he's gone a heckuva lot or else he really makes a ton of money in his office. In HOOKED I described a family doc in California who was said to not schedule any patients between 10:30 and 2:30 each day, so that he could get away to give lunch-time drug talks at any location within an hour's drive of his office--and by doing so cleared an extra $160,000 a year. I'm sure that just barely covered his overhead, too.
Quote: Most of the money Hansen received came from Eli Lilly. Hansen said he spoke ... about a disease state associated with major depressive episodes. He talked about new research on neuroimagery and genetics and didn’t discuss Eli Lilly’s product for the disease....“It’s truly an educational series just based on education related to illness,” Hansen said.
Translation: Since it's education and not marketing, it must be just a coincidence that Eli Lilly pays for this, and pays for it out of its marketing budget. Drug companies know exactly how to teach docs about "the mechanisms and genetics of disease" in such a way that the take home message is that one and only one drug is best for the condition. Or else they just stress drug treatment for the disease in general, knowing that their drug has a certain percentage of market share, and that if docs prescribe any drug, they'll pick up that percentage.
Now we'll give the good Dr. Hansen a respite and go to the section of the article about local hospital systems and their regulations about conflicts of interest.
Quote: Southwest Washington Medical Center prohibits pharmaceutical representatives from holding raffles, drawings or “other activities that lead to personal gifts for providers or employees.” The policy also says doctors — most of whom are not employees of the hospital but partner with its Southwest Medical Group — “should not directly solicit or receive personal gifts from pharmaceutical companies.” Southwest does not prohibit doctors from receiving payment for work that they do with pharmaceutical companies, however.
Translation: Southwest has no effective rules.
Quote: Legacy Health System’s policies say payments, reimbursements or subsidies should not be accepted to cover travel or to compensate for time spent away from practice. Limited exceptions apply for doctors who incur out-of-pocket expenses, and only then under certain conditions. Legacy directly employs about 900 people in Clark County, 30 to 40 of whom are doctors, spokesman Brian Willoughby said. Legacy’s administrative policy — which is updated every three years, most recently in January — prevents doctors with whom it contracts from accepting cash or cash equivalents. It also prohibits doctors from accepting gifts totaling more than $75 per year from any given vendor. Willoughby said the policy covers foundation board members and members of Legacy’s management team, not just its doctors. “We hire people with integrity,” Willoughby said.
Translation: Legacy seems to be starting off from a serious stance about physician COI. The next question is that now the data on physicians' take from Pharma is starting to become available, whether anyone at Legacy has consulted the figures for their physician employees, to see if they are actually complying with the policies.
From Health Care Renewal: Logical Fallacies in Epstein's Denunciation of COI Reg
Just a quick cross-post to our colleagues at the Health Care Renewal blog:
http://hcrenewal.blogspot.com/2010/11/there-you-go-again-richard-epstein-says.html
Dr. Roy Poses discusses a recent blog posting by Prof. Richard Epstein of the University of Chicago and New York University law schools (funny thing; as an academic I have always found it as much as I could manage to work for one institution at a time; I never tried working for two). (Link to Epstein posting is in URL above) Prof. Epstein is a strong defender of the so-called free market and believes that undue restrictions on financial conflicts of interest are stifling important innovation in Pharma. (What else would you expect? The blog on which he posted his comments is called "The Libertarian.") One of Dr. Poses' special hobbies, which warms my philosophical heart, is to analyze people's arguments in search of logical fallacies. He finds a whole raft of them in Epstein's recent post and lists them all for your edification.
For earlier mention of Prof. Epstein in this blog, see http://brodyhooked.blogspot.com/2007/08/epstein-vs-relman-debate-to-overlook.html
http://hcrenewal.blogspot.com/2010/11/there-you-go-again-richard-epstein-says.html
Dr. Roy Poses discusses a recent blog posting by Prof. Richard Epstein of the University of Chicago and New York University law schools (funny thing; as an academic I have always found it as much as I could manage to work for one institution at a time; I never tried working for two). (Link to Epstein posting is in URL above) Prof. Epstein is a strong defender of the so-called free market and believes that undue restrictions on financial conflicts of interest are stifling important innovation in Pharma. (What else would you expect? The blog on which he posted his comments is called "The Libertarian.") One of Dr. Poses' special hobbies, which warms my philosophical heart, is to analyze people's arguments in search of logical fallacies. He finds a whole raft of them in Epstein's recent post and lists them all for your edification.
For earlier mention of Prof. Epstein in this blog, see http://brodyhooked.blogspot.com/2007/08/epstein-vs-relman-debate-to-overlook.html
Friday, November 5, 2010
Genentech's Secret Rebates for Lucentis Eye Injections
Thanks to our friends over at Postscript, we learn of the article by Andrew Pollack in the New York Times:
http://www.nytimes.com/2010/11/04/business/04eye.html?scp=1&sq=andrew%20pollack%20genentech%20offers%20secret&st=cse
This seems to be the latest chapter in the Lucentis-Avastin saga:
http://brodyhooked.blogspot.com/2007/10/retinal-specialists-get-integrity-award.html
Genentech's problem: It manufactures both Avastin, a cancer drug, and Lucentis, a drug made from the active portion of the same molecule as Avastin (a classic "me too drug" strategy). Avastin injected into the eye is very good for treating wet macular degeneration. A dose of Lucentis for this indication costs $2000 while a dose of Avastin (used off label) costs $20-50. Looked at another way, in 2008, Medicare paid for 480,000 injections of Avastin, because so many retinal specialists (to their credit) want to use the cheaper but equally effective drug. Only 337,000 injections of Lucentis were paid for that year. Yet the smaller number of Lucentis injections cost the US taxpayer $537M compared to $20M for the Avastin.
Genentech would love to get more docs to use Lucentis, which this year has reached blockbuster drug status in the US with $1.1B in sales, especially before the results of a large scale trial are reported next spring, which many predict will show Avastin to be either the same or even better than Lucentis for this disease.
The answer: a rebate program that rewards docs who use high volumes of Lucentis and who increase their use of Lucentis from quarter to quarter. This is legal, but it seems interesting from an ethical standpoint that Genetech has operated this program in secret. Docs who sign up have to promise not to reveal even the existence of the program, let alone its terms.
Dr. Greg Rosenthal, one of the leaders among retinal specialists for the cost-saving use of Avastin, is quoted in the article, "There's no way to look at [the rebate program] without calling it bribery." The American Academy of Ophthalmology has said it will investigate. The bribery seems to be working--Lucentis sales are up 29% in the first 9 months of 2010.
http://www.nytimes.com/2010/11/04/business/04eye.html?scp=1&sq=andrew%20pollack%20genentech%20offers%20secret&st=cse
This seems to be the latest chapter in the Lucentis-Avastin saga:
http://brodyhooked.blogspot.com/2007/10/retinal-specialists-get-integrity-award.html
Genentech's problem: It manufactures both Avastin, a cancer drug, and Lucentis, a drug made from the active portion of the same molecule as Avastin (a classic "me too drug" strategy). Avastin injected into the eye is very good for treating wet macular degeneration. A dose of Lucentis for this indication costs $2000 while a dose of Avastin (used off label) costs $20-50. Looked at another way, in 2008, Medicare paid for 480,000 injections of Avastin, because so many retinal specialists (to their credit) want to use the cheaper but equally effective drug. Only 337,000 injections of Lucentis were paid for that year. Yet the smaller number of Lucentis injections cost the US taxpayer $537M compared to $20M for the Avastin.
Genentech would love to get more docs to use Lucentis, which this year has reached blockbuster drug status in the US with $1.1B in sales, especially before the results of a large scale trial are reported next spring, which many predict will show Avastin to be either the same or even better than Lucentis for this disease.
The answer: a rebate program that rewards docs who use high volumes of Lucentis and who increase their use of Lucentis from quarter to quarter. This is legal, but it seems interesting from an ethical standpoint that Genetech has operated this program in secret. Docs who sign up have to promise not to reveal even the existence of the program, let alone its terms.
Dr. Greg Rosenthal, one of the leaders among retinal specialists for the cost-saving use of Avastin, is quoted in the article, "There's no way to look at [the rebate program] without calling it bribery." The American Academy of Ophthalmology has said it will investigate. The bribery seems to be working--Lucentis sales are up 29% in the first 9 months of 2010.
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