It has been a good while since I reported on drugs like epoetin, used to stimulate the body to make more red blood cells to counteract the anemia associated with end-stage kidney disease and cancer. My early post: http://brodyhooked.blogspot.com/search?q=dialysis-- commented mostly on the payment system that tempted dialysis and cancer docs to prescribe more of these drugs than was necessary or safe. But new information now suggests that the truth about the harms and lack of benefit of these drugs could have been known much sooner and many patients saved from bad outcomes. Sadly this is not the first such story in the history of the medicine-pharmaceutical industry relationship.
Dr. Daniel W. Coyne, a kidney specialist at Washington University-St. Louis, has both written a detailed paper and a briefer commentary about his research:
http://the-scientist.com/2012/05/14/opinion-misleading-drug-trials/
http://www.nature.com/ki/journal/vaop/ncurrent/full/ki201276a.html
I'm going to go into some detail about Dr. Coyne's findings as they illustrate several points, both about how scientific studies can be fudged to create a positive drug marketing message, and also how our bureaucracy works (or doesn't) to protect patient safety.
Before more recent research in the mid-2000s showing quite definitively that higher doses of epoetin-type drugs produced more strokes and other bad outcomes, the main research trial informing kidney guideline writers was the Normal Hematocrit Trial, conducted in 1996 and published in the New England Journal in 1998: http://www.nejm.org/doi/full/10.1056/NEJM199808273390903 This study was stopped early because of concerns that the higher doses of epoetin were causing more adverse reactions (more on that later). The journal article reported that on careful statistical analysis, there were no serious safety issues found, but that by contrast, quality of life of patients improved in the groups receiving the higher doses of epoetin (that is, those whose red blood cells achieved higher levels, which usually requires higher doses of the drug).
What Dr. Coyne did was simple. The drug company, Amgen, had to submit its own report of the study data to the FDA. As usually is the case, the FDA is under no obligation publicly to release these data and is indeed usually prevented from doing so by the proprietary nature of a company-sponsored study. Dr. Coyne requested the FDA data under the Freedom of Information Act, and was able to obtain the data after being kept waiting a mere 3-1/2 years (more on that later too). He then sat down and compared in detail the study data reported to the FDA to the same study reported in the medical journal in 1998.
First the safety data. According to the New England Journal, the primary study endpoint, death or non-fatal heart attack, showed no difference between the high- and lower-dose groups. But the reason that the authors concluded this was that the data monitoring board, that stopped the study early, insisted on a tighter threshold for statistical significance, reportedly to correct for the fact that the same data had undergone multiple prior statistical analyses. The usual threshold is P = 0.05, but with the demand for the stricter level of P = 0.008, there was no statistically significant difference. When Coyne looked at the data the drug company submitted to the FDA, he saw that with the unadjusted significance test, there were more adverse events in the higher-dose group, with P = 0.0119, which would normally be interpreted as quite a significant result.
Time out for a sidebar on early stoppage of clinical trials. As I previous blogged--for example, http://brodyhooked.blogspot.com/2011/03/how-honest-reports-of-research-can.html-- in the past, when drug trials are stopped early because a drug seems superior to the control, it is commonly found with later research that this result is spurious and that had the trial been continued to scheduled completion, there would have been no difference between drug and placebo (or other comparator). What we see in the case of the Normal Hematocrit Trial appears to suggest a double standard for industry-sponsored trials. If the trial is stopped early because the company's drug looks good, then that result is trumpeted as the truth, even if more study would cast doubt on that conclusion. If on the other hand a study is stopped early because the drug causes people to die, then the investigators get to move the goalposts and fudge the statistics, so that it turns out that those people did not really die after all. Without going into all the issues about whether data monitoring boards are truly independent of the study sponsors, and how early stopping can lead to misleading results even of the boards are totally kosher, it would seem a valid take-home lesson that we should authomatically be very skeptical whenever a drug trial is stopped early.
Now, back to the main story and the question of benefits. Dr. Coyne found that the study as reported in the New England Journal indicated benefit in quality of life for patients who had achieved higher red blood cell counts. Reportedly these findings were statistically significant at P = 0.03. When he reviewed the same data as reported to the FDA, he could find no evidence of any statistically significant improvement, with a single exception--it was indeed true that patients getting higher epoetin doses ended up requiring fewer blood transfusions.
So the bottom line--in 1998 the kidney dialysis community was told that higher epoetin doses, leading to higher red cell counts, posed no significant risk of harm and improved patients' quality of life. Based mostly on that one study, the kidney gurus issued several practice guidelines calling for higher levels of red cells, which in turn required docs to prescribe higher doses of epoetin. Around 2006-8, new data emerged suggesting that this was unsafe. In hindsight we now realize that the data from 1996-98 actually show the same thing, and indeed demonstrate lack of any benefit to boot; so between 1998 and 2008, however many dialysis patients were exposed to serious risks of harm, including death, with no corresponding benefit. In total, says Dr. Coyne, Amgen profited to the tune of $37B in total sales of epoetin.
Now for the bureaucracy piece. Dr. Coyne filed his FOIA request for the FDA data in January 2008. He finally received the data in July 2011. Two weeks before he received the data, the FDA issued new labeling for epoetin, calling for lower red blood cell levels. In its warning, the FDA accepted the statistical tests of the data on file, meaning that the FDA now belatedly rejected the statistical fixes that had been published in the New England Journal. He allows us to read whatever we want into the timing of these events.
In his opinion article, Dr. Coyne also reports having contacted some of the academic authors of the New England Journal version of the Normal Hematocrit Trial. They claimed to him that they had tried to insert the information that he later discovered into the published paper, but that the editors at the journal rejected those amendments. Dr. Coyne admits to skepticism, since these same authors published several later papers and also served on the kidney guideline committees, but never made any attempt to alter the impression given by the original publication.
In HOOKED, I mention a couple of other instances where patients suffered due to a delay in revealing the truth about the benefits and harms associated with a drug--Vioxx being the poster child, having caused an estimated 144,000 excess heart attacks during the years when its dangers should have been known. We now have to add epoetin to this dishonor roll.
Many thanks to Dr. Barbara Roberts, author of The Truth About Statins, for calling my attention to this work.
Showing posts sorted by relevance for query dialysis. Sort by date Show all posts
Showing posts sorted by relevance for query dialysis. Sort by date Show all posts
Friday, May 18, 2012
Saturday, January 5, 2008
Lobbying Congress on Anemia Drugs: How Not to Take Care of Patients
Here's a recipe for taking rotten care of some especially needy and vulnerable patients.
The first thing you do is set crazy reimbursement rules for cancer centers and kidney dialysis clinics. You promise to reimburse the physicians based on a percentage of the costs of the drugs that they administer by injection.
I think back to my days as a practicing family physician and wince. Suppose the people in control had told me that if I saw a patient, diagnosed an ear infection, and prescribed a cheap but ideal antibiotic like amoxicillin, I'd get paid $40 for the office visit. If I prescribed two different antibiotics, I'd get $60. And if I prescribed some unnecessary but very expensive antibiotic like Zithromax, I'd get $80. How would that payment system have distorted my prescribing habits? I am glad I never had to find out.
But my colleagues in kidney and cancer care have gotten used to such a reimbursement system--to the extent that for some cancer clinics, these drug administration fees account for fully 1/3 of their revenue. How likely are those physicians to recommend a shorter rather than a longer course of chemotherapy, or a less expensive rather than a more expensive drug, even if the patient would benefit?
Now, into this crazy reimbursement formula you add an anemia drug like Epogen or Procrit. These are very expensive drugs, made by a fancy recombinant-DNA biotech system. The drugs make up for the fact that patients with cancer or with kidney failure fail to make enough of a substance that tells the bone marrow to make more red blood cells, leading to an anemia that can make the patients weaker.
The good news is that in moderate doses, these drugs restore the red cell count and make the patients feel stronger. The bad news is that in higher doses, these drugs, we now know, increase the risks of stroke significantly, and also, in some cases, create a risk for faster tumor growth.
How likely are the docs who are paid on a commission basis--that seems to be what it amounts to, call it what you will--to cut back on the doses they administer, when dispensing higher doses means higher revenues for their clinics?
Medicare, that pays for all of dialysis care and the lion's share of cancer care, finally realized it had a real problem on its hands. So in 2007 they proposed a new rule--they'd pay only for the moderate doses but not for the risky, high doses of these anemia drugs. Which, from a medical point of view, makes perfectly good sense, across the board and in general.
That meant a financial hit to the companies that make the drugs--Amgen and Johnson & Johnson. Both, but especially Amgen, responded with an over-the-top lobbying effort. They complained that some patients, who actually needed the higher doses because of individual treatment factors in order to feel strong enough, would be denied what their doctors recommended for them under the new Medicare rules. (Federal bureaucrats tell doctors how to practice medicine! Film at 11!) They cranked up the "astroturf" (so-called "grass roots" organizations that supposedly represent patients, but that are in fact heavily bankrolled by the drug companies).
As the Wall Street Journal recently reported, the effects have been stunning. Amgen topped all the drug firms in its lobbying expenses for the first half of 2007 ($9.1M). In exchange, both houses of Congress have introduced legislation to overturn the Medicare rules. (Of course, the American Society of Clinical Oncology that represents the cancer docs has joined in opposing the new rules.) Congress tells Federal bureaucrats how to tell doctors how to practice medicine! Film at 11! (Actually, the fate of this legislation is hard to predict, since if it does not pass, Medicare will continue to bleed red ink and Congress will have to find some way to increase tax support for the program. The costs for these anemia drugs is one of the single fastest-growing items in the Medicare budget.)
So what would a person say who actually cared about what happens to patients--as clearly neither Congress, nor Amgen, nor the physicians any longer give a hoot about? It may be that the new Medicare rules are really too burdensome and too awkward to determine which patient needs what dose of these drugs. So maybe the rules are in fact a bad idea and need to be modified.
But pardon me if I believe that the underlying problem that has to be fixed is paying docs a commission for prescribing more and more expensive drugs to certain categories of patients. And if the oncologists and dialysis physicians are offended because I just said that they don't care about their patients any more, I reply--fine; if you want us to believe that you really care about the patients, then join us in changing the way you get paid. If you continue to demand to be paid by a commission formula, unlike most other medical specialties, who in their right minds would ever believe you, that you are truly patient advocates?
Timiraos R. Amgen spends big protesting curbs on anemia drugs. Wall Street Journal, Nov. 13, 2007:B1-B2.
The first thing you do is set crazy reimbursement rules for cancer centers and kidney dialysis clinics. You promise to reimburse the physicians based on a percentage of the costs of the drugs that they administer by injection.
I think back to my days as a practicing family physician and wince. Suppose the people in control had told me that if I saw a patient, diagnosed an ear infection, and prescribed a cheap but ideal antibiotic like amoxicillin, I'd get paid $40 for the office visit. If I prescribed two different antibiotics, I'd get $60. And if I prescribed some unnecessary but very expensive antibiotic like Zithromax, I'd get $80. How would that payment system have distorted my prescribing habits? I am glad I never had to find out.
But my colleagues in kidney and cancer care have gotten used to such a reimbursement system--to the extent that for some cancer clinics, these drug administration fees account for fully 1/3 of their revenue. How likely are those physicians to recommend a shorter rather than a longer course of chemotherapy, or a less expensive rather than a more expensive drug, even if the patient would benefit?
Now, into this crazy reimbursement formula you add an anemia drug like Epogen or Procrit. These are very expensive drugs, made by a fancy recombinant-DNA biotech system. The drugs make up for the fact that patients with cancer or with kidney failure fail to make enough of a substance that tells the bone marrow to make more red blood cells, leading to an anemia that can make the patients weaker.
The good news is that in moderate doses, these drugs restore the red cell count and make the patients feel stronger. The bad news is that in higher doses, these drugs, we now know, increase the risks of stroke significantly, and also, in some cases, create a risk for faster tumor growth.
How likely are the docs who are paid on a commission basis--that seems to be what it amounts to, call it what you will--to cut back on the doses they administer, when dispensing higher doses means higher revenues for their clinics?
Medicare, that pays for all of dialysis care and the lion's share of cancer care, finally realized it had a real problem on its hands. So in 2007 they proposed a new rule--they'd pay only for the moderate doses but not for the risky, high doses of these anemia drugs. Which, from a medical point of view, makes perfectly good sense, across the board and in general.
That meant a financial hit to the companies that make the drugs--Amgen and Johnson & Johnson. Both, but especially Amgen, responded with an over-the-top lobbying effort. They complained that some patients, who actually needed the higher doses because of individual treatment factors in order to feel strong enough, would be denied what their doctors recommended for them under the new Medicare rules. (Federal bureaucrats tell doctors how to practice medicine! Film at 11!) They cranked up the "astroturf" (so-called "grass roots" organizations that supposedly represent patients, but that are in fact heavily bankrolled by the drug companies).
As the Wall Street Journal recently reported, the effects have been stunning. Amgen topped all the drug firms in its lobbying expenses for the first half of 2007 ($9.1M). In exchange, both houses of Congress have introduced legislation to overturn the Medicare rules. (Of course, the American Society of Clinical Oncology that represents the cancer docs has joined in opposing the new rules.) Congress tells Federal bureaucrats how to tell doctors how to practice medicine! Film at 11! (Actually, the fate of this legislation is hard to predict, since if it does not pass, Medicare will continue to bleed red ink and Congress will have to find some way to increase tax support for the program. The costs for these anemia drugs is one of the single fastest-growing items in the Medicare budget.)
So what would a person say who actually cared about what happens to patients--as clearly neither Congress, nor Amgen, nor the physicians any longer give a hoot about? It may be that the new Medicare rules are really too burdensome and too awkward to determine which patient needs what dose of these drugs. So maybe the rules are in fact a bad idea and need to be modified.
But pardon me if I believe that the underlying problem that has to be fixed is paying docs a commission for prescribing more and more expensive drugs to certain categories of patients. And if the oncologists and dialysis physicians are offended because I just said that they don't care about their patients any more, I reply--fine; if you want us to believe that you really care about the patients, then join us in changing the way you get paid. If you continue to demand to be paid by a commission formula, unlike most other medical specialties, who in their right minds would ever believe you, that you are truly patient advocates?
Timiraos R. Amgen spends big protesting curbs on anemia drugs. Wall Street Journal, Nov. 13, 2007:B1-B2.
Monday, August 26, 2013
The Fate of a Scientist Who Reveals Drug-Related Harms? The Bennett Case
Initially, our friend Dr. Roy Poses blogged about this on
Health Care Renewal:
I was tempted also to blog about this but held off at the
time because I was concerned that the facts were not all available, and it was
just possible that I would be defending someone who was, in fact, guilty of
fraudulent behavior—a concern Dr. Poses shared because he called for more
investigation.
Dr. Poses has meanwhile posted again:
--and in turn referenced an article by Paul Goldberg in The Cancer Letter of Aug. 9:
--which now seem to provide enough factual background to at
least raise some serious concerns. Let’s see if I can tell this tale the right
way around for our purposes, even though it’s a convoluted story.
Let’s go back to the debate over drugs like epoetin that are
used in kidney dialysis and cancer care to treat anemia by stimulating the
production of red blood cells:
Companies like Amgen, that manufactured these lucrative
drugs, were quite upset when studies began to show that higher doses of the
drugs increased blood counts by too much and led to life-threatening clotting
complications. The problem was that both cancer docs and dialysis centers were
being paid on commission, meaning if they used higher doses, they got more
money, and so had a strong financial incentive (which of course also benefited
the drug’s manufacturer) to use the higher doses. Dr. Charles Bennett of
Northwestern University med school played a role in reporting both on the
scientific evidence of harm from too-high doses, and later on the role of the
drug firms in trying to hide this information—for example:
Dr. Bennett eventually created a unit at Northwestern, the
Research on Adverse Drug Events and Reports project, specifically to study
serious adverse drug reactions; and it is not too much of a stretch to suggest
that his work helped to create the climate in which Amgen pleaded guilty to
charges that it misbranded its epoetin drug Aranesp and paid a settlement of
$762M in 2012. When Dr. Bennett left Northwestern in 2009, it was to take the
offer of $6M in startup funds to study the safety of drugs in South Carolina.
Now let’s look at issues at Northwestern regarding the
administration of research grants.
As Goldberg recounts, Northwestern has previously had
problem in this area, and a decade ago had to repay the NIH $5.75M that it
obtained through inflated reimbursement for faculty effort. Just recently,
Northwestern agreed to pay the Feds a settlement of about $3M due to
questionable payments on another grant, in this case one whose principal
investigator was Dr. Bennett.
Just before this recent Federal settlement was announced, a
former Northwestern employee, Feyifunmi Sangoleye, pleaded guilty in U.S.
District Court to embezzling $86,000. She worked in the Northwestern cancer
division’s grants administration office and set up a phony account, into which
she proceeded to divert grant monies that she eventually used to pay for a
wedding in Europe.
The statements issued by the Feds and by Northwestern
regarding their recent settlement focus on the allegations that Dr. Bennett
used NIH grant funds illegally to pay for consulting jobs for family members
and for personal travel unrelated to the grant. The whistleblower credited with
exposing this wrongdoing, and who as a result takes home a nearly
half-million-dollar share of the award, is Melissa Theis, who was a temp
employee at Northwestern in 2007-8. What Goldberg finds intriguing about her
role is that she apparently never worked directly in the cancer center, so it’s
unclear how she obtained information about Dr. Bennett’s grant.
In the normal course of events (as Dr. Poses stressed) Dr.
Bennett could not simply pay himself money out of his grant and do whatever
with it. He had to submit the expenses to the administration, and they had to
approve that the costs were justified before any payment could be issued. The
people who would have had to sign off would have been first, the administrator,
the recently convicted felon Sangoleye, and the director of the cancer center,
Dr. Steven Rosen. Dr. Rosen was initially listed as a co-defendant but his name
was dropped as the Federal settlement proceeded.
Dr. Bennett told Goldberg that he did not do any of the
things alleged regarding inappropriate payments, that he noted irregularities
in the way Northwestern was handling grant funds, and that he duly reported
these concerns to his superiors before leaving Northwestern.
The publicity surrounding the Federal settlement was what
first attracted Dr. Poses’ attention. The Chicago newspapers jumped on the
charges against Dr. Bennett, but completely ignored the Sangoleye guilty plea.
Both Northwestern and the Feds seemed primarily interested in alleging that it
was all Dr. Bennett’s fault and specifically in clearing Dr. Rosen of any
wrongdoing, even though officially he was the person where the buck stopped in
approving payouts from the grants.
Goldberg talked with several colleagues of Dr. Bennett who
testified that he was not the sort of person one would expect to commit fraud
with grant money, and was in fact a scientist dedicated to sniffing out the
truth about adverse drug reactions.
Goldberg hints broadly in the article that Dr. Bennett
collected his share of foes due to his work on epoetin drugs and their dangers,
and that it would not be that strange if at least some of all this recent
scandal reflected an effort to smear his reputation. And given that the
administrator who oversaw his grant is now a convicted felon, if anyone played
fast and loose with money from his grant, it might well not have been Dr.
Bennett. And, finally, if there was lax supervision of grants at Northwestern,
it would seem that Dr. Rosen and not Dr. Bennett should be answering for it.
Monday, December 24, 2012
Yet Another Silly "Integrity"" Agreement: Amgen and Aranesp
Okay, now we can go back to the standard form:
Company: Amgen
Drug: Aranesp (darepoetin alfa)
Offense: Marketing drug for off-label uses (anemia in all cancer patients when approval only for patients receiving chemotherapy)
Amount of settlement: $762M (including both criminal and civil penalties)
Settlement is what percentage of annual revenues from drug sales: 38%
Did company admit wrongdoing: Yes, pleaded guilty to one misdemeanor account
The facts are summarized in the usual insightful post by Dr. Roy Poses at Health Care Renewal:
http://hcrenewal.blogspot.com/2012/12/amgen-settles-pleads-guilty-to.html
--which in turn cites the New York Times:
http://www.nytimes.com/2012/12/19/business/amgen-agrees-to-pay-762-million-in-drug-case.html?_r=0&adxnnl=1&adxnnlx=1356376699-qWKLtjN7sro23upHGgd5Yg
All this is same song, third verse for readers of this blog who might remember these previous two posts:
http://brodyhooked.blogspot.com/2012/05/hiding-truth-about-drugs-how-long-are.html
http://brodyhooked.blogspot.com/2008/01/lobbying-congress-on-anemia-drugs-how.html
--on which more in a minute. Basically, drugs to treat anemia in both cancer patients and kidney dialysis patients have been pushed heavily by drug companies, despite evidence (that was successfully hidden for some years) that higher doses of these meds, leading to higher blood counts, actually caused more patient deaths by leading to blood clotting. Aranesp is one of this family of drugs (generally referred to as epoetins). While as a technicality Amgen was nailed on off label marketing for claiming that all cancer patients, and not just those on chemotherapy, needed their red blood cells boosted up with this medication, the real offense was aggressively pushing the drug despite risks of harm.
Now, as the older of the two previous posts made clear, the blame for this sad state of affairs only partially lies with the drug firm, though they clearly did everything they could to milk extra profits even over the bodies of dead patients. The other part of the puzzle is the crazy way the Feds have reimbursed kidney dialysis and cancer docs. They are virtually the only physicians paid on commission for prescribing either more expensive drugs, or higher doses of drugs. So when Amgen came to these docs and said, your patients have this terrible anemia, use our expensive drug to boost their red cell count, and don't worry about those nasty rumors about lack of safety when you use the highest possible doses, they were preaching to the choir, as these docs pocketed extra money both for using the drug in the first place and also for using more of it. As I said in the original post, how anyone could be so insane as to imagine that such a system would result in high-quality patient care truly amazes me, and I'm pretty much beyond being amazed.
As is his constant refrain, Dr. Poses notes that no one at Amgen is doing any jail time, or even is worried about it, after the company pleaded guilty to criminal charges. When the drug, even now that docs have finally been warned and are using less of it, sells $2B worth every year, the company can easily afford a $700M settlement. In the face of these business realities--just pay your fine and go your merry way, and no company executive will ever suffer personally--then the fact that Amgen signed a "corporate integrity agreement" as part of the settlement remains nothing but a really bad joke. It was only as short time ago that we (thanks again to Dr. Poses) noted the repeat offenses of another company that has now signed enough corporate integrity agreements to paper the CEO's suite:
http://brodyhooked.blogspot.com/2012/12/doing-it-again-after-pomising-not-to.html
Company: Amgen
Drug: Aranesp (darepoetin alfa)
Offense: Marketing drug for off-label uses (anemia in all cancer patients when approval only for patients receiving chemotherapy)
Amount of settlement: $762M (including both criminal and civil penalties)
Settlement is what percentage of annual revenues from drug sales: 38%
Did company admit wrongdoing: Yes, pleaded guilty to one misdemeanor account
The facts are summarized in the usual insightful post by Dr. Roy Poses at Health Care Renewal:
http://hcrenewal.blogspot.com/2012/12/amgen-settles-pleads-guilty-to.html
--which in turn cites the New York Times:
http://www.nytimes.com/2012/12/19/business/amgen-agrees-to-pay-762-million-in-drug-case.html?_r=0&adxnnl=1&adxnnlx=1356376699-qWKLtjN7sro23upHGgd5Yg
All this is same song, third verse for readers of this blog who might remember these previous two posts:
http://brodyhooked.blogspot.com/2012/05/hiding-truth-about-drugs-how-long-are.html
http://brodyhooked.blogspot.com/2008/01/lobbying-congress-on-anemia-drugs-how.html
--on which more in a minute. Basically, drugs to treat anemia in both cancer patients and kidney dialysis patients have been pushed heavily by drug companies, despite evidence (that was successfully hidden for some years) that higher doses of these meds, leading to higher blood counts, actually caused more patient deaths by leading to blood clotting. Aranesp is one of this family of drugs (generally referred to as epoetins). While as a technicality Amgen was nailed on off label marketing for claiming that all cancer patients, and not just those on chemotherapy, needed their red blood cells boosted up with this medication, the real offense was aggressively pushing the drug despite risks of harm.
Now, as the older of the two previous posts made clear, the blame for this sad state of affairs only partially lies with the drug firm, though they clearly did everything they could to milk extra profits even over the bodies of dead patients. The other part of the puzzle is the crazy way the Feds have reimbursed kidney dialysis and cancer docs. They are virtually the only physicians paid on commission for prescribing either more expensive drugs, or higher doses of drugs. So when Amgen came to these docs and said, your patients have this terrible anemia, use our expensive drug to boost their red cell count, and don't worry about those nasty rumors about lack of safety when you use the highest possible doses, they were preaching to the choir, as these docs pocketed extra money both for using the drug in the first place and also for using more of it. As I said in the original post, how anyone could be so insane as to imagine that such a system would result in high-quality patient care truly amazes me, and I'm pretty much beyond being amazed.
As is his constant refrain, Dr. Poses notes that no one at Amgen is doing any jail time, or even is worried about it, after the company pleaded guilty to criminal charges. When the drug, even now that docs have finally been warned and are using less of it, sells $2B worth every year, the company can easily afford a $700M settlement. In the face of these business realities--just pay your fine and go your merry way, and no company executive will ever suffer personally--then the fact that Amgen signed a "corporate integrity agreement" as part of the settlement remains nothing but a really bad joke. It was only as short time ago that we (thanks again to Dr. Poses) noted the repeat offenses of another company that has now signed enough corporate integrity agreements to paper the CEO's suite:
http://brodyhooked.blogspot.com/2012/12/doing-it-again-after-pomising-not-to.html
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