I thought the fine sounded large, but the last paragraph of the article puts it in context:
> Despite the large fine, $3bn is far less than the profits made from the drugs. Avandia has made $10.4bn in sales, Paxil took $11.6bn, and Wellbutrin sales were $5.9bn during the years covered by the settlement, according to IMS Health, a data group that consults for drug makers.
Not really, we don't know what the profit margin is. A quick search says from 10-20%, though another site says 40%. So it may have wiped out a significant chunk of profit.
Yeah that's true — I was a bit misled by that sentence. I read "sales" as "profit," thinking that the author quoted those numbers because they were able to be used as a comparison to gauge the severity of the fine.
"Over the years, thousands of people taking or withdrawing from Paxil or other psychiatric drugs have committed violent acts, including suicide, experts said, though no firm statistics are available. Because many factors could have contributed to that behavior, it is still far from clear who is at risk — and for whom the drugs are protective."[1]
So we have a case where thousands of people we're put at a big risk,with clearly illegal practices , and nobody is going to jail ? and on the other hand, no major systemic change has happened - like taking the responsibility for clinical testing , and drug advertising out of drug developer's hands ?
Not playing devil's advocate here, but just to point out why things that seem obviously black-and-white don't seem to be nipped in the bud. Drug companies are not allowed to advertise drugs for any reason than what they were officially approved for. However, doctors are allowed to have discretion in this matter...for example, if they know a certain drug prescribed only for, say, hair loss, is also good for erectile dysfunction, and they've read enough of the literature to prescribe this confidently...then they don't have to go strictly by FDA regulations.
This freedom is not a bad thing in itself...I mean, it reflects the reality that have effects (good and bad) that are independent of a regulatory process. One extreme case that I can remember is when Avastin -- originally prescribed to fight cancer -- was found to be as effective for treating eye disease at $50 a pop as a drug that cost $1,950 [1]...and so there was controversy over whether doctors should be allowed to prescribe Avastin before it was officially approved by the FDA for this usage.
So it became obvious to drug companies that if they advertise/befriend doctors, they could influence them to prescribe drugs for these off-label uses. Maybe some of those uses were completely legitimate (and profitable). Some obviously should not have been pushed for off-label use, such as highly-addictive painkillers approved only for use by the most serious cancer afflictions being prescribed to people with migraines. When you consider that highly competitive pharma sales reps had the ability to basically know exactly how much each doctor prescribed on a weekly (daily?) basis, and thus, how much to visit and chat them up...you basically have a bunch of not-technically-illegal-things that were maybe fine on their own, but added up, eventually, to what the Justice Dept. considered to be fraudulent activity.
I don't want to say this is just old news, because we should always be watching for the possibility that this kind of loophole allows this behavior to persist...but things have changed a bit since even a few years ago.
For starters, the Centers for Medicare & Medicaid Services finally implemented the law that required healthcare companies to submit records of their payments to doctors:
...and that fine was much less than the profits it made. However, the move towards posting payments online (which happened just last year) has made doctors less enthusiastic about hanging out with sales reps. This is not to say there isn't another way profit motive can push the rules, of course, just that attitudes pre-2012 may be different compared to now.
edit: Just in case I'm getting downvoted for sounding blasé about the issue...I launched this investigative project in 2010: https://projects.propublica.org/docdollars/ -- so I've read a lot about the topic and about this particular lawsuit back in the day ...but even before then, scrutiny of pharma ties was gaining momentum and causing doctors and companies to rethink having blatant relationships. In the OP, the 2012 suit is based off of investigations of activities years before...Dr. Pradko receiving $2M, for example, happened in 2001-2003 [1]
This is not to say there won't be corruptive influences ever again...just that it probably won't be so obvious in the fashion described in this 2012 lawsuit. If Dr. Pradko had gotten $2M post-2010...that would be shocking.
"...the company paid $275,000 to Dr Drew Pinsky, who hosted a popular radio show...Pinsky, who had not declared his GSK income to listeners, said Wellbutrin could give women 60 orgasms a night."
Article may be older, but it begs the question - can you trust anything the big pharma produces? How about vaccines which could be safe but aren't, because they simply don't have to? How about a true cancer cure being suppressed? Do you still find it hard to believe?
Btw this is a big reason why drugs are more expensive in the US vs other countries: US Doctors essentially demand bribes in the form of CME-credit holidays, post-FDA fake clinical trials as a kick-back, lucrative consulting and speaking gigs etc. Pharma then increases price relative to other countries. Best of all, the US medical community, with specialists making 300K-1M+, gets to blame evil Pharma for higher drug prices, while being one of the primary beneficiaries of the price bump. Hypocrisy at its "best".
My advice is explicitly ask your doc if they receive any incents / cash from any company whose drugs they prescribe you. Get this in writing.
Many/most healthcare companies do not allow pharmaceutical and device manufacturers to reimburse their providers for their travel/accommodations for CME anymore.
Market segmentation is a big part of the difference in costs between here (US) and there (everywhere else) -- not because the cost of marketing their drug is more here, but that people/insurance plans are willing/able to pay more than they are elsewhere.
I'm currently in the process of scheduling my first annual physical in a few years and had narrowed down my choice of in-network providers who are accepting new patients to two physicians.
Using the link you provided, I see one received $988 in drug company money for the period covered, the other $669. The one recommended to me by a friend who is no longer accepting new patients: $1387.
So I guess I can combine that information with a handful of 3 and 4 star reviews for each on healthgrades.com and throw a dart at a map.
The US Justice Dept has publicly said that Justice is better served by seeking huge fines against banks (and presumably other large organizations) instead of criminal prosecution against individuals.
I was going to be devil's advocate and say they technically haven't said that, but since they cited collateral consequences of prosecution like costing thousands of jobs[1], that pretty much is them saying their way was the most just way. [1] http://www.theguardian.com/commentisfree/2012/dec/12/hsbc-pr...
I think threats to "jobs" are right up there with pedophilia and terrorism. Won't somebody please think of the jobs?!!
Ben Goldacre's excellent book, Bad Pharma, discusses doctor-pharma bribery in detail.
One fact which stuck with me was how, doctors are universally concerned about how other doctors are constantly being gifted and dined by other pharma reps, but they are convinced that they are personally immune from these attentions because obviously these things don't work on them.
I often wonder - why do doctors fall for this? Why do they participate in what is clearly a manipulative scam? When they know that patients and the community and even their taxes go to paying for expensive marketing budgets?
Part of the problem is that there is an unfortunate climate of entitlement among doctors. This issue has probably been studied rigorously but I suspect that being treated as 'special' all your life combined with difficult and prolonged training in often less than friendly environments breeds the feeling that you are entitled to special treatment.
I think, honestly, the other problem is that Americans don't take any holidays (in general, compared to Europe, Australia, New Zealand). I know lots of doctors that just take Thanksgiving off. So when you offer a very busy person an educational conference that is actually a holiday in disguise, they are going to be quite susceptible. Not to say that doctors elsewhere don't willingly travel to pharma fantasy island at every opportunity.
They're not falling for anything, its just plain and simple greed. My father was in the radiology area and he constantly received 'bribes' (didn't accept them, but had the offers).
Perhaps, it just sounded like you thought these very intelligent (for the most part) doctors, were unaware of what they were accepting, which isn't the case.
It's very clear in the industry that it goes on, and anyone that partakes is a scumbag, in full knowledge of what they're doing.
This in an industry that is meant to heal people, not be part of the problem we're facing with rampant corporatism and out of control greed.
28 comments
[ 3.7 ms ] story [ 82.4 ms ] thread> Despite the large fine, $3bn is far less than the profits made from the drugs. Avandia has made $10.4bn in sales, Paxil took $11.6bn, and Wellbutrin sales were $5.9bn during the years covered by the settlement, according to IMS Health, a data group that consults for drug makers.
So we have a case where thousands of people we're put at a big risk,with clearly illegal practices , and nobody is going to jail ? and on the other hand, no major systemic change has happened - like taking the responsibility for clinical testing , and drug advertising out of drug developer's hands ?
How will anybody learn ?
[1]http://www.nytimes.com/2015/09/17/health/antidepressant-paxi...
This freedom is not a bad thing in itself...I mean, it reflects the reality that have effects (good and bad) that are independent of a regulatory process. One extreme case that I can remember is when Avastin -- originally prescribed to fight cancer -- was found to be as effective for treating eye disease at $50 a pop as a drug that cost $1,950 [1]...and so there was controversy over whether doctors should be allowed to prescribe Avastin before it was officially approved by the FDA for this usage.
So it became obvious to drug companies that if they advertise/befriend doctors, they could influence them to prescribe drugs for these off-label uses. Maybe some of those uses were completely legitimate (and profitable). Some obviously should not have been pushed for off-label use, such as highly-addictive painkillers approved only for use by the most serious cancer afflictions being prescribed to people with migraines. When you consider that highly competitive pharma sales reps had the ability to basically know exactly how much each doctor prescribed on a weekly (daily?) basis, and thus, how much to visit and chat them up...you basically have a bunch of not-technically-illegal-things that were maybe fine on their own, but added up, eventually, to what the Justice Dept. considered to be fraudulent activity.
[1] http://www.wsj.com/articles/SB100014240527023048680045773763...
> Tuesday 3 July 2012 12.19 EDT Last modified on Wednesday 1 October 2014 07.41 EDT
Nothing to see here. Move along, citizen.
For starters, the Centers for Medicare & Medicaid Services finally implemented the law that required healthcare companies to submit records of their payments to doctors:
https://www.cms.gov/openpayments/
This law came about after several massive Justice Dept. settlements around 2008 to 2010. In 2009, at the time Pfizer paid the largest health care fraud settlement in history at $2.3B: http://www.justice.gov/opa/pr/justice-department-announces-l...
...and that fine was much less than the profits it made. However, the move towards posting payments online (which happened just last year) has made doctors less enthusiastic about hanging out with sales reps. This is not to say there isn't another way profit motive can push the rules, of course, just that attitudes pre-2012 may be different compared to now.
edit: Just in case I'm getting downvoted for sounding blasé about the issue...I launched this investigative project in 2010: https://projects.propublica.org/docdollars/ -- so I've read a lot about the topic and about this particular lawsuit back in the day ...but even before then, scrutiny of pharma ties was gaining momentum and causing doctors and companies to rethink having blatant relationships. In the OP, the 2012 suit is based off of investigations of activities years before...Dr. Pradko receiving $2M, for example, happened in 2001-2003 [1]
This is not to say there won't be corruptive influences ever again...just that it probably won't be so obvious in the fashion described in this 2012 lawsuit. If Dr. Pradko had gotten $2M post-2010...that would be shocking.
[1] http://www.pharmpro.com/news/2012/07/complaint-doctors-were-...
My advice is explicitly ask your doc if they receive any incents / cash from any company whose drugs they prescribe you. Get this in writing.
> CME-credit holidays
Many/most healthcare companies do not allow pharmaceutical and device manufacturers to reimburse their providers for their travel/accommodations for CME anymore.
Market segmentation is a big part of the difference in costs between here (US) and there (everywhere else) -- not because the cost of marketing their drug is more here, but that people/insurance plans are willing/able to pay more than they are elsewhere.
Using the link you provided, I see one received $988 in drug company money for the period covered, the other $669. The one recommended to me by a friend who is no longer accepting new patients: $1387.
So I guess I can combine that information with a handful of 3 and 4 star reviews for each on healthgrades.com and throw a dart at a map.
I think threats to "jobs" are right up there with pedophilia and terrorism. Won't somebody please think of the jobs?!!
PS Does anyone have video of that press conference? I think I found the documents here (http://www.justice.gov/opa/documents-and-resources-december-...) but it would be interesting to see the questions and answers that The Guardian summarized.
1) Shouldn't people be going to jail?
2) Shouldn't the bribe-takers also be punished, and have their licenses revoked?
One fact which stuck with me was how, doctors are universally concerned about how other doctors are constantly being gifted and dined by other pharma reps, but they are convinced that they are personally immune from these attentions because obviously these things don't work on them.
Part of the problem is that there is an unfortunate climate of entitlement among doctors. This issue has probably been studied rigorously but I suspect that being treated as 'special' all your life combined with difficult and prolonged training in often less than friendly environments breeds the feeling that you are entitled to special treatment.
I think, honestly, the other problem is that Americans don't take any holidays (in general, compared to Europe, Australia, New Zealand). I know lots of doctors that just take Thanksgiving off. So when you offer a very busy person an educational conference that is actually a holiday in disguise, they are going to be quite susceptible. Not to say that doctors elsewhere don't willingly travel to pharma fantasy island at every opportunity.
It's very clear in the industry that it goes on, and anyone that partakes is a scumbag, in full knowledge of what they're doing.
This in an industry that is meant to heal people, not be part of the problem we're facing with rampant corporatism and out of control greed.